Medical Device Business Magazine-Medical Device News and Articles | Massive Equipment

August summary of first-level recalls: 244 second-level recalls: 171

Release date, recalled manufacturer, product name/product, reason for recall

August 8, 2014 enhanced medical treatment; LLC enhanced medical expression-enhanced medical expression. Model # EXP-150. Injectable gel 1.5cc syringe with a hyaluronic acid concentration of 20 mg/ml. Product use: Expression is labeled as an intranasal splint; it is designed to reduce bleeding and edema, and prevent adhesion between the nasal septum and the nasal cavity. However; Expression is currently used as a dermal filler for subcutaneous injection off-label. The manufacturer made changes to the production process, resulting in a change in the final gel weight. Recall expansion 7/8/2014 The company expanded the scope of the recall to include all batches of products.

August 14, 2014 Cardiovascular System; Inc. Diamondback 360 Peripheral Orbital Plaque Resection System. – CSI Cardiovascular Systems; Company; Diamondback 360 Peripheral Orbital Plaque Resection System; Model DBP-125MICRO145; Part Number 7-10003. Diamondback 360 peripheral orbital atherectomy system is a percutaneous orbital atherectomy system, which is suitable for the treatment of patients with peripheral arterial atherosclerosis and is acceptable for percutaneous endoluminal plaque resection. Candidate. OAS supports the removal of stenotic materials from artificial arteriovenous dialysis fistulas (AV shunts). The system is a percutaneous intraorbital plaque resection system, which is suitable for the treatment of patients with occlusive hemodialysis grafts who undergo percutaneous intraluminal angioplasty. CSI has begun to recall the Diamondback 360 peripheral orbital plaque resection device because it may contain a saline sheath that may rupture; break; and release particles during use.

Synthesized on August 20, 2014; Inc. DePuy Synthes Craniomaxillofacial Distraction System – DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) DePuy Synthes began to recall certain batches of craniomaxillofacial distraction system (AB Distractor Bodies and BC Distractor Bodies) because they may be reversed-operationally.

Children’s Medical Risks on August 20, 2014 Gel-E Donuts; Squishon 2 – Gel-E Donuts; Squishon 2 Gel Pillow Product Usage:: This product is designed to support and cradle the baby’s head and/or body . The rectangular shape of Squishon products allows the head to move while maintaining a supporting surface and provides effective ventral support for the prone position. The round shape of Gel-E Donut products helps reduce stress caused by long periods of inactivity or other situations that prohibit frequent repositioning. The gel-filled Gel-E Donut and Squishon product lines have received many complaints about visible mold. The molds detected were identified as Cladosporium and Penicillium; this is a common mold.

Cook Inc. CloverSnare 4-ring vascular repair snare on August 27, 2014 – CloverSnare 4-ring vascular repair snare. The product is packaged with Tyvek film, which can be sterilized, and comes in a box and a bag. CloverSnare 4 Ring Vascular Retriever is designed to be used in the cardiovascular system to manipulate and retrieve foreign bodies; including but not limited to; wire guides; coils; balloons; catheters; and filters. This remedy is the result of six product complaints related to the separation of the snare from the distal end of the wire.

August 28, 2014 Smiths Medical ASD; Inc. Portex Tracheal Intubation Stent-4001PS Neonatal/Paed. Intubation Kit 2.5mm Murphy; LDS 15mm ConnPediatric Endotracheal Intubation Kit The tube fasteners on the ET tube stent may be damaged during use Compress the tracheal tube, which may cause difficulties in locking the ET tube stent in place or passing the suction tube.

August 28, 2014 Smiths Medical ASD; Inc. Portex endotracheal stent – ​​H4052 endotracheal stent; Pedi 3.0 mm pediatric endotracheal intubation kit The tube fastener on the ET tube stent may compress the endotracheal tube during use. This may make it difficult to lock the ET tube stent in place or to pass the suction catheter.

August 28, 2014 Smiths Medical ASD; Inc. Portex Endotracheal Stent – ​​H4051 Endotracheal Stent; Pedi 2.5 mm Pediatric Endotracheal Intubation Kit The tube fasteners on the ET tube stent may compress the endotracheal tube during use , Which may cause difficulties in locking the ET tube holder in place or passing through the suction catheter.

August 28, 2014 Smiths Medical ASD; Inc. Portex Tracheal Intubation Stent – ​​H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy; 15mm cable; stent Pediatric Tracheal Intubation Kit ET tube stent tube fasteners The tracheal tube may be compressed during use, which may make it difficult to lock the ET tube stent in place or to pass the suction tube.

August 28, 2014 Smiths Medical ASD; Inc. Portex Tracheal Intubation Stent – ​​H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy; 15mm Conn; Stent Pediatric Tracheal Intubation Kit ET tube stent tube fasteners in use The tracheal tube may be compressed at times, which may make it difficult to lock the ET tube stent in place or to pass the suction tube.

August 28, 2014 Smiths Medical ASD; Inc. Portex Tracheal Intubation Stent-H4002PS Neonatal/Paed. Intubation Kit 3.0mm Murphy; LDS 15mm ConnPediatric Endotracheal Intubation Kit The tube fasteners on the ET tube stent may be damaged during use Compress the tracheal tube, which may cause difficulties when locking the ET tube stent in place or passing the suction tube.

Customized on August 29, 2014; Inc Customed – Face Pack- BOD; Code 900-3027; Contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) Towel absorbent 15" X 20" (1) DRAPE INSTRUMENT MAGNETIC 10" X 16"(1) Tray half depth (1) Anti-needle/blade/20GMA (1) Enhanced MAYO bracket (1) Piece ENT split 110" X 77"(1) Enhanced cover table 44" X 78 "(20) Gauze Sponge 4" X 4" 12PLY(6) Towel Cloth Bhak C1 Blue) CUP DENTTURE 8oz TEAL WITH LID(1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER(2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK(2) LITE GLOVE product use: EO sterilization operation convenient packaging, packaged in a polyester/polyethylene breathable bag Tyvek double vent. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Laparotomy Kit-Customized-(1) Bag suture flower (2) Towel absorbent 15" X 20" (1) MAYO support cover reinforcement (1) Drape T Laparotomy STD SMS (2) Single piece hanging 42" X 57" 1) Table cover reinforcement 50" X 90" (4) Hanging practical packaging with convenient packaging for TAPEEO sterilization operation, packaged in polyester/polyethylene breathable with Tyvek double vents The customer in the bag has determined that the packaging integrity of different catalog numbers may be affected (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF (I) TROCAR XCEL BLADELESS II MM(I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF (I) NEEDLE ULTRA VERES 120MM TUB- LIFINS(I) Ring Adapter LIF(I) Pendant Video Camera 13cm X 244 em LIF(I) Pendant Knee and Abdomen Pouch 1 02"" X 1 22"" X 78"" STD SMS(2) Tights 7" "Cuff 30" X 42"" (I) SAFETY SCALP EL # II S/STEEL(I) GOWN IMPERV. XTRA REINF. XL T/WRAP LEVEL III (I) TABLE COY ER REINFORCED 50"" X 90"" LIF( 4) DRAPE UTILITY WIT APE LIF(2) DRAPE SI-IEET 42"" X 57"" SMS(I) TUBE SUCTION CONNECT Y."" X 1 2′ LIF(I) MAYO STAND COYER REINFORCED LIF (1 0) Gauze Sponge 4" "X 4"" 16PLY XRD LIF (4) Towel absorbent 1 5"" X 20"" LIF(2) LITE GLOVE(I) Hip drape PO UCl-144"" X 35"" (2) Syringe I Occ with 0 needle LILOCK LIF (2) Specification IMEN CONTA INER 4 oz with cap and label (1 5) Knee sponge prewash 18" X 1 8"" XRD LIF (I) PVP paint 8"" stick sponge ( I) Practical bowl quart 32oz LIF (I) Dual electrode DEPRES(I) DRESSING OPSITE POST PO 2!12 X 2""(I) MERLINO SK ready to use. 39ML LIF(3) GOWM XL SMS IMPERVIOUS REINFORCED LIF(I) Umbilical cord laparoscopic monopolar food switch (1) FOLEY catheter kit includes: (I) catheter 1 6FR FOLEY 2WAY; Sec(I) PYP TR IPLE SWABSTICK IODOPHOR (2) SWABSTICK DRY COTTON(I) SYR I NGE IOcc WaterREFIL LIF(2) GLOVE MED FREETOUCH YYN ILP/F (I) TOWEL3PLYPOLY 17"" X 18""(4I) D ""FEENSTRATED 18"" X 26" "(I) LABEL ID PATIENT(I) JELLY LUBRI CATING 5 GRAM(I) Urine Bag Drainage 2000ML Anti-reflux LIF (I) Tray SBS(I) Packaging 24"" X "Product Usage: Convenient packaging for EO sterilization operation, Packed in a polyester/polyethylene breathable bag with Tyvek double vents. "The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may result in harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – Tummy Tuck Pack- FJG; Code 900-3114; Contains: (2) Dress large SMS IMPERVIOUS REINFORCED AAMI Ill (2) Towel absorbent 15" X 20" (1) Pencil Scorch the bottom ST. Holster (1) Needle 22G X 1 Y2 (2) Syringe 20CC without needle Luer lock (1) Anti-needle and blade 20C foam/magnetic (2) Bowl 32 ounces 32 ounces. (1) Cover (1 inch serrated bayonet cover with knife cover) with ruler (1) Ruler (1) Reinforced cover meter 50" X 90" (2) 8 ounce cup with lid denture blue green (6) Terry cloth HUCK blue (1) pipe straw connector X" X 12'(1) YANKAUER straw without air holes (1) sheet% drape enhanced type 60" X 77"(4) drape practical, with tape (1 0 ) Knee sponge pre-wash 18" X 18" XRD(1) blade surface treatment. #15 carbon steel(1) blade reinforcement. #1 0 carbon steel(1) syringe bulb 60cc(2) PR. GLOVE SURG. CUSTOMGUARD Chlorine Butadiene rubber #6.5 P/F(2) PR. Glove SURG. CUSTOMGUARD CHLOROPRENE #7 P/F(1) PR. GLOVE GUARD CUSTOMGUARD. Neoprene #7.5 P/F(1) SKIN STAPLE 35 wide(1) overhang Top with adhesive 108" X 50" STD SMS(2) Overhang side 42" X 76" With tape(1) Overhang bottom ABS reinforcement 71" X 66" STD SMS WITH TAPE(1 0) GAUZE SPONGE 4" X 4" 16 PLY(1) PK. STRIP STERI CLOSURE WX 4" Product use: EO sterile surgical convenient bag is packed in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-obstetric surgery kit; code 900-2940; contains: (1) blanket receiving 100 cotton (3) towel absorbent 15 X 20 LIF (10) gauze sponge 4 X 4 16PLY XRD LIF (1) Syringe ear/ulcer 2 ounces. LIF(1) Abdomen drape belt 40X54 LIF(2) Legging belt 7-inch cuffs 30X42 L/F(1) Robe XL SMS IMPERVIOUS reinforced LIF(1) OB cushion wrapped overnight (1) Table cover 50X1X90 hip drape cloth belt bag 44X35"(1) Umbilical Cord LIF(1) Bowl Plastic 80 oz. LIF(1) Bowl Cover 80 oz. Transparent LIF(1) Peas Baby(5) Knee Sponge Pre-wash XRD(11X1X) SM (1) DRAPE SHEET 41X58 SMS LIF(1) UNDERPAD 36X36 BEIGE(1) VAGINAL PACKING XRD 4X36 8PLY 100% COTTON(10) GAUZE SPONGE 4X4 16PLY LIF Product use: EO Tyve disinfection and breathable double-layer polyester bag/polyethylene packaging bag vent. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-LAP AROSCOPY bag-(10) Gauze sponge 4" X 4" 16-layer XRD LIF (1) MAYO bracket cover reinforcement L/F (4) Adhesive bandage %" X 3" ST . LIF(1) Table cover reinforcement 50" X 90" LIF(2) Robe impermeable reinforcement large SMS(2) Towel absorbent 15" X 20" LIF(1) Pleated laser camera W/EL 6" X 96" LIF( 2) LITE GLOVE LIF(1) Tube suction connection WX 12' LIF(1) Hanging knee with bag 102" X 121" X 78" STD SMS(1) Blade surgery #11 stainless steel(1) Syringe 10cc (without LIFLE) Lock) 4) With L/F tape (1) Bag stitching flower (1) Draping utility for TUY suit; 2 Lead L/F (2) Needle and blade counter 1 OC MAG/transparent LIF (1) Tunic standard large SMS Velcro (1) pipe suction connector 3/16" X 12' LIF(1) Pk. STERI band circle. Latex (1) Container specimen 4 ounces with lid and label (1) Cautery pencil rocker switch LIFEO Sterilization operation convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-OB bag-(2) Exam gloves MED. (1 0) Gauze sponge 4" X 4" 12PL Y (2) Tights with 7" cuffs (2) Suspended piece SMS( 1) Abdominal drape/tape (1) Plastic bowl with lid 70 oz. (1) Ear/ulcer syringe 2 oz. L/free (1) Umbilical cord clamp (1) Baby beans (1) PVP scrub 8" stick sponge (1) Measurement display. Paper tape 24"(1) IMP .REINFORCED GOWN XLge. SMSSTERILE(1) Table cover Reinf. L/Free(1) Syringe 1cc W/NDL. 25G X 5/8 SLIP TIP L/Free(2) PAD OBSTETRICAL XLGE ST .(1) Lower hip drape/bag (1) Syringe 10cc W/0 NDL. L/Free(1) Syringe 20cc W/ONDL. L/Lock L/Free(1) Feeding tube 8 Fr. 15" LONG( 1)) Importer of baby blankets. POLY ABS.(1) NEEDLE HYPODERMIC 23GA X 1"(6) ABSORBENT TOWELS L/Free(1) WRAPPER 24" X 24"EO sterile surgical convenient packaging, packed in polyester/polyethylene breathable bag with Tyvek double Vent. The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-NEURO PACK-(1) CAUTERY TIP POLISHER LIF (4) Draping utility with tape LIF (1) Instrument bag (10) Knee sponge prewash XRD (1) Pk. Surgical strip W'X 6"(2) Practical bowl 32oz(1) MAYO tray large(9) Cover cloth 41" X 69" Medium LIF(1) Needle 18G X 1 LIF(3) Container specimen and​​4oz Laboratory(2) Pr. Surgical Gloves 7 Y2(2) Pr. Surgical Gloves 8(2) Ear Ulcer Syringe 2oz LIF(1) Syringe 10cc Without Needle LUER Lock LIF(1) Flaky Small Knee 102" X 781" 1) Safety scalpel #10 (2) Syringe 60 ml without needle LUER lock LIF (4) Buhak towel blue (1) Pencil burning rocker switch (2) Trouser leg with 7 inch cuff 30" X 42"(1) ECONO DRA 53" X 77" LIF(1) Pk. Surgical strip'X" X 6"(10) Gauze sponge 4" X 4" 16PLY XRD LIF(1) Table cover reinforcement 50" X 90" LIF(2) Needle and blade counter 1 OC MAG/transparent L/F(2) Round wash basin 6QT(2) Surgical gown. Reinforced towel/wrap large(2) Pr. Surgical gloves 7(1) LIF with ruler (1) Pk skin marking. STERI strip closure %"X 4" LIF(1) tube suction connection.'X" X 12' LIF(1) SAFETY SCALPEL #15(1) SAFETY SCALPEL #11L/FEO sterile Convenient packaging for surgery, packed in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that there is a possibility that the integrity of the packaging may be compromised due to different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – Face Pack MRT; product code 900-2654; including: (2) GOWN SOFT SMS STD X-Large SET IN SLEEVE LIF(2) TOWELS ABSORBENT 15 X 20 LIF(1) DRAPE INST. Magnetic 10 X 16 LIF(1) Tray half depth(1) Cover MAYO bracket reinforced LIF(1) Plate ENT split 110 X 77 SMS LIF(1) Cover table reinforcement 44" X 78" LIF(20) Gauze X44 12 Layer L/F(6) Terry cloth HUCK C Blue L/F(2) Absorb water. Apply the stick sponge LIF(1) strip STERI to close the LIF(1) cup denture 8 ounces. Blue-green with cap (1) Skin marking ink with 8 labels/timeout/ruler life cycle (2) Syringe 10 ml dark green (1) Syringe 10 ml yellow L/F (1) LITE glove life cycle (1) reverse Needle and blade/20C MAG LIF Product use: EO sterile surgical convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – Breast Pack MRT; Code 900-2658; Contains: (1) bulb syringe 60cc (2) GOWN SOFT SMS STD XLGE set in the sleeve (1) cauterizing pencil push bottom (2) Syringe 10cc with 0 needle Luer lock (1) Needle and blade counter (1c/2MA)) Utility bowl 1/4 quart 32 ounces (1) Reinforced Mayo stand cover (1) Reinforced table cover 50 X 90( 1) Suspended breast/chest SMS(1) YANKAUER straw with 0 vents(1) Tube straw(1) RNNULECT 6 CLEAR(6) TOWEL CLOTH CLOTH C (BLUE)(2) TOWEL ABSORBENT 15 X 20(2) SKIN MARKER INK W/ LABEL(1) DENTTURE CUP 8oz W/LID(2) LITE gloves Product use: EO disinfection surgery convenient bag is packed in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – LAPAROTOMY BASIC PACK-CUSTOMED- (1) Table cover reinforcement 44" X 78" LIF(1) Cover MAYO support reinforcement UF(2) Towel absorbent 15" X 20" UF( 1 0) X gauze sponge XRD 4" 4"-12PL Y(2) DRAPE SHEET 41" X 58" SMS UF(4) DRAPE UTILITY WITH TAPE L/FEO Convenient packaging for disinfection operation, packed in polyester/polyethylene breathable bag , Customization with Tyvek dual vents has determined that there is a possibility that different catalog numbers (multiple batches) may affect package integrity. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "customized-ear bag content: (I) B LADE SU RG ICA L # 15 carbon steel (I) EMESI S BASIN 10 700cc(I) GOWN XL SMS IM P. Reinforcement (I) Needle-shaped subcutaneous IC 1'8G XI (I) Washbasin round 6QT(I) Instrument bag 7 X II 2COMPARTMENT (I) STERI STR IP closed'h"" X 4""(I) Syringe 3cc without needle LILOCK ( 2) Syringe I MLLOCK without needle) CAUTERY TIP POLISHER(I) Sheet ENT SPLIT 110"" X 77"" SMS(I) GOWN I MP XTRA REINF. SMS XLT/W LEVEL IV (2) LITE GLOVE(1 2) TOWELS CLOTH HUCK (BLUE)(I) Tube suction connection W'X 1 2'(I) Ear ulcer syringe 2oz(I) Table COYER reinforced 50"" X 90""(I) Practical bowl 16oz(4) Applicator Cotton 6"" Wood (2) PE STRJPS 24"" X 4""(I) GOWN LGE SMS I MPERVIOUS REINFORCED (I) Wipe instrument LMM 8.25 X 8.25 (I) MAYO Stand COYER Reinforce (I) Needle and blade counter 20c Foam/MAG (I ccy) NEEDLE LILOCK(I) MAYOTRAY SMALL(I) Syringe I Occ TI P CONTROL LUER LOCK (I) DRAPE M ICROCOSPE LE I CA 42 X 105(I) TI ME OUT BEACON Non-woven fabric (I) Blade M Extra-large carbon steel (10) Gauze sponge 4"" X 4"" 1 6PLY XRD (I) SK IN MARKER INK W/8 label (2) Needle HYPODERM IC 27G XI W'ONE PACK WET SKIN contains the following: (I) Wrap SMS 30"" X 30"" (2) Cotton tip applicator 6"" wood (2) Gloves MED FREETOUCH VYNIL P/ F (6) Sponge wing small (4) Absorbent towel 1 5"" X 20 "" (3) Suction head. Sponge stick (I) PVP iodophor paint 4 ounces. Bottle (I) PVP scrub solution 4 oz. BOTTLE (I) TRAY 3/COMPARTMENT product use: EO sterilization surgery convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. "The customer has determined that different catalog numbers (multiple batches) may affect package integrity. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – NEURO PACKCONTENTS: (4) TOWEL ABSOSRBENT 15"" X 20"" LIF (I) BAG BI OH AZARD 30"" X 37"" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4"" X 4"" 1 6PLY XRD UF(I) CAUTERY POLISHER TIP LIF(I) Blade SU RGICAL# II Carbon Steel(I) Tray MAYO LARGE(8) Terry cloth Il UCK (blue) (2) Washbasin round 6QT (I)) Needle injection 1 8G XI \12 ST. (2) UTI LITY BOWL QUART 32oz. (2) Bulb syringe 60cc LIF (2) Needle and blade counter; IOC M/CLEAR LIF (2) PVP scrub 8 inch stick sponge (I) SKIN STAPLE 35 wide ST. LIF(2) Syringe 60 ml W/0 needle LILOCK LIF(2) LITE GLOVE(I) Form COYER BTC 79"" X 110" "HD full coverage LIF (2) pipe suction connection. W'X 1 2'LIF (4) DRAPE UTILI TY WIT APE LIF(5) LAP SPONGE PREWASH 1 8"" X 1 8"" XRD LIF (I) CAUTERY Pencil ROCKER SWITCH UF (2) BLADE SURG I CA L # IO Carbon Steel (I) Blade Surgical I CAL#1 5 Carbon Steel (I) Skin Marking Ink W/8 Label (3) UTI LITY Bowl 1 6 oz. L/F (2) PVP paint 8"" Stick Sponge ST. (7) DRA polyethylene: V. ECONOMY 53"" X 77"" LIF(I)S UTURE BAG FLORAL(I) SY ring I Occ SLI P TI P ST. LIF(I) Needle hypodermic IC 22G XI \12 ST.(I) SOLUTION SURG I CAL DURAPREP 26M L LIF(I) GOWN SURG. Reinforced LGE towel/cloth (2) Robe FAB Reinforced X Large SONTARA( I) Pendant TLAPAROT. 1 02"" X 78"" X 1 21"" STD SMSProduct Usage: EO sterilization operation convenient packaging, packed in a polyester/polyethylene breathable bag with Tyvek double vents. "The customer has determined that the integrity of the packaging may be affected by different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-knee arthroscopy kit; code 900-2718; contains: (1 0) gauze sponge 4 X 4 12PL Y(2) PADDING CAST SOFT ROLL 6 X 4yds.(1) GoBan Self-Adherent wrap 6 X 5yds(3) PAD ABDOMINAL 8 X 7.5(1) Dressing 1 X 8 XEROFORM PETROLAT(10) Gauze sponge 4 X 4 16PLY XRD(3) Needle injection 18G X 1 (1) Needle spinal anesthesia 18G X 3 (1) Needle injection 22G X 1 (1) 3 needle/needle/needle) Scalpel with handle 11 (1) Skin marking with ruler (9) Skin marking label (1) Ruler (3) Pr. GLOVESURG 8 DERMA PRENE powder-free (1) Bandage elastic knit standard 10 yards (1) Bandage ESMARK 6 X 9 yards (8) Terry cloth HUCK blue (1) U-Drape 60 X 70 WIT APE SPLIT 6 X SHEET 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) BOWL UTILITY 16oz. (1) Cover reinforcement 50 X 90 (2) GOWN SURGICAL REFORCED X-LARGERS1 T/WRAP (2) Towel absorbent 15X 20( 1) STOCKINETTE IMPERV 12 X 48(2) BAG PLASTIC 6 X 12(1) Knee Joint Surgical Towel(1) FILTER STRAW 5 MICRO(2) LITE Glove Product Usage: EO sterile packaged in polyester with Tyvek double vents /Polyethylene breathable bag. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customized-Extreme Arm Package Content: (1) STOCKINTE IMPERVIOUS 14"" X 48"" (1) GOBAN Self-adhesive Wrap 6"" X 5yds (3) Bandage Elastic 4"" X 5yds(1) Bandage ESMARK 6"" X 9 (1) Practical bowl quart 32 ounces (10) Gauze sponge 4"" X 4"" 16PLY(1) Tube suction connection 12'(1) Skin marking ink ribbon 8 Label/timeout/ruler (3) Scraper with handle # 15 stainless steel (1) timeout beacon non-woven fabric (1) hood (1) overhang cutout antibacterial 23"" X 17"" (2) needle and blade counter 10c MAG /Transparent (1) 60 U-DRA ""X 70"" WITH TAPE SPLIT 6"" X 21"" (1) Spinal cord anesthesia 18G X 3% (3) Long gown X large impermeable reinforcement (1) MAYO bracket Cover reinforcement (4) DR APE utility with tape (6) Towel absorbent 15"" X 20"" (3) Overhang% ECONOMY 53"" X 77""(1) YANKAUER OPEN TIP CLEAR W/0 CN( 1) CAUTERY TIP POLISHER (1) Suture bag flower (1)) Dress SURG enhanced X large towel and wrap (1) MERLING skin preparation applicator 39ML (1) One-handed 146"" X 104"" X 91"" (1) Table cover reinforced 50"" X 90"" Product use: EO sterile packaged in a polyester/polyethylene breathable bag with Tyvek double vents. "Customed has been confirmed, different catalog numbers (multiple) Batches) packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – ARTHROSCOPY PACK I (1) CUSTOMEDCONTENTS: (1) TOWELS ABSORBENT 15"" X 20""(1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED(1) U – DRAPE 60"" X 70 ""WITAPE SPLIT 6 X 21(1) Paging paper with adhesive 108"" X 77"" STD SMS (1) STOCKINETTE IMPERVIOUS 12"" X 48""(4) 24"" X 4""(1)) Suture bag flower(1) Sheet arthroscopy T STD SMS with bag(1) Table cover reinforcement 44"" X 78""(1) Usage GOWN SURG. REINFORCED XLGE TOWEL I WRAPProduct:EO The sterile surgical kit is packaged as a polyester/polyethylene breathing bag with Tyvek dual vents.” Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – EENT PACK ICUSTOMEDCONTENT: (2) TOWEL ABSORBENT 15"" X 20""(1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL(1) SHEET SPLIT 110"" X 77"" SMS(1) Table cover reinforcement 50"" X 90"" (1) Hanging head W!TAPE 44"" X 26""(1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP Packed into a polyester/polyethylene breathable bag with Tyvek double vents.” Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-basic packaging with outerwear-(1) table cover reinforcement 50" X 90" UF(4) with UF(1) towel absorbent 15" x 20" L/F(1 ) Sewing bag of flowers (1) Suspended piece 42" X 57" SMSg~ piece o/. 57" X 63" Reinforced SMS UFMAYO Stand Cover Reinforced UFEO Convenient Packaging for Sterilization Operation, Packaged in a Polyester/Polyethylene Breathable Bag with Tyvek Double Vents. Customized. Packages with different catalog numbers (multiple batches). Integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-squint and plastic packaging-(1) Table cover reinforcement 44" X 78" UF(2) Robe standard large SMS(3) Towel absorbent 15" X 20" UF(1) MAYO bracket cover reinforcement UF(1) Curtain SHEET 41" X 58" SMS(4) DRAPE UTILITY WITH TAPE L/FEO Sterilization operation convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-OB bag-(I) PVP SCRUB 8" Stick SpongES(I) Underbuttok Drap with Pouch(2) with 7" cuff 30" x 42" (I) Abdominal drape LIF( I) Vaginal wrap sponge XRD(I) I) Plastic bowl with lid 80 ounces(I) Receiving blanket 100% cotton(I) Baby blanket polymer absorbent impermeable(I) Umbilical cord clip(4) Towel absorbent 15" x 20" life 6 ounces (I) 2 WLUTIL tray organizer full depth (3) TIP absorbent applicator (2) glove check medium (2) robe large SMS impermeable reinforcement (10) gauze sponge 4" X 4 "12PLY(2) Pad Maternity X-LA Ulcer Syringe 2 oz. LIF(I) Baby beans(2) Sheet 4 1" x 58" SMS LIF(I) Scissors umbilical cord (I) Table cover reinforcement 50" x 90" LIF(2) Package 24" X 24" L/f Product use: EO Sterilization Surgery Convenience Pack, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that packaging integrity may be affected by different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Customized Cysto Tur Pack; Convenience Pack includes multiple components: leggings with cuffs; drape cystoscopy; towel absorbent and tablecloth. Convenient packaging for EO sterilization surgery, packaged in a polyester/polyethylene breathable bag with Tyvek double vents, Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Basic Pack FPSC Florham Pack; code 900-2969; includes: (1) bed cover enhanced version 50" X 90" (10) gauze sponge 4" X 4" 16-layer XRD(1 ) Cover Mayo bracket reinforcement (2) GOWN SOFT SMS STD. X-Large AAMI Ill(1) Anti-needle and blade 20C foam/MAG (2) Towel absorbent 15" X 20"(4) Draping utility with tape(1) 24" X 24"(8) Labels are used 1.25 Mark "X %" (2) LITES GLOVE(1) MARKER SKIN WITH RULER (1) BLADE SURGICAL# 15 CARBON STEEL(1) RULER(5) SPONGE LAP PREWASH 18" X 18" XRD Product use: EO sterilization surgery Convenient packing polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – CURATION Kit – CUSTOMED- (10) gauze sponge 4" X 4" 16PL Y(4) water-absorbent applicator (4) PVP preparation solution 1 oz (1) container sample 4 oz With lid and label (2) Inspection gloves (1) WRAPPER 24" X 24" UF(1) Packaging TRAYEO is a convenient packaging for sterilization and surgery, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Caesarean section package- (1) Reinforced cover table 50" X 90" (2) Absorbent towel 15" X 20" (1) Baby blanket printing (1) Bowl plastic with cover 80 ounce. (2) Needle and 10C blade counter MAG/CLEAR(1) Umbilical cord clamp(1) MUCUSTRAP 20cc; 10FR.(1) BOWL UTILITY 32oz(1) C-Section Drape with Pouch 102" X 121" X 78"(1) TUBE SUCTION CONNECT.~"X 12'(1) TIP CAUTERY POLISHER(1) Pencil sharpener switch(2) Dress anti-seepage reinforcement large SMS(1) MAYO support cover reinforcement(10) Knee sponge prewash 18" X 18" XRD(1) bag glass(2) surgical blade #10 stainless steel(1) earplug ULCER2 2) LIGHT GLOVE(1) BOWL UTILITY 16oz(4) DRAPE UTILITY WITH TAPE(2) DRAPE SHEET 41" X 58" SMS(1) ELECTRODE DUAL DEPRES./GROUNDPADEO Convenient packaging for sterilization surgery, packed in a polyester/polyethylene breathable bag with double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – CENTRAL LINE DRAPE PACK1) MASK PROCEDUAL LOOP 120MM HG V/BL/Free(1) DRAPE SHEET 41" X 58" SMS L/Free(1) CAP NURSE 21" GREEN BOUFFANT( 1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED CIRC/FENE (1) WRAPPER 24" X 24" GOWN LGE STANDARD SMS VELCRO NECK TOWELS ABSORBENT 15" X 20" L/FreeProduct Usage: EO sterilization operation convenient package packaged into polymer Ester/polyethylene vented bag with Tyvek double vents. The customer has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility .

Customized on August 29, 2014; Inc Customed – Lithotomy Pack III (3); Code 900-2487; Contains: (3) Towel absorbent 15" X 20" (1) Large standard SMS Velcro for robe (2) Leggings with 7" cuffs 30" X 42"(1) Pleated lower hip belt pocket 44" X 35"(1) Pleated ABDOMINAL WITH TAPE 40" X 54"(1) DRAPE UTILITY WITH TAPE(1) Cover Table Reinforced 50" X 90" Product use: EO sterilization surgery convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be possible Will be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customized-Central Line Full Body Suspended Body Curtain" Content: (1) 30"" X 30"" (2) Surgical mask with mask anti-fog 160 mmHg (2) Nurse Cap 21"" green fluffy (2) absorbent towel ""X 20""(2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41"" X 58"" SMS(1) DRAPE BRACHIAL ANGlO 44"" X 31"" REINFORCED 3"" sticky round FENESTRATION:EO sterilization operation convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Universal Cosmetic Packaging FCSC; Code 900-3113; Contains: (1) COVER MAYO STAND REINFORCED LIF(10) LAP Sponge PREWASH 18" X 18" XRD LIF(2) GOWN LARGE STANDARD SMS AAMIIII(1) Table cover reinforcement 50" X 90" LIF(2) Towel absorbent 15" X 20" LIF(1) YANKAUER straw without exhaust LIF(1) Syringe bulb 60CC LIF(1) Surgical blade# 15 Carbon steel(1) Needle 18G X 1% LIF(6) Terry cloth LIFHUCK DRAPE Utility with TAPE L/F(1) Needle injection 25 X 1% L/F(1) Syringe 20CC without needle LUER lock life( 2) Syringe 10CC without NNEDEL LUER lock life(2) Needle X20" LIF(1) Skin mark LIF with ruler(1) Anti-needle and blade 20C foam/MAG L/F(1) LITE GLOVE(1) Dangling breast /Chest SMS LIF(1) pipe suction connection %" X 12' LIF( 10) gauze sponge 4" X 4" 16PLY L/F(2) glove medium FREETOOUCH VYNIL Powder FREE(1) tray 3/COMPARTMENT(1) Wrapping paper 24" X 24" L/F(2) PK. Surgery. GLOVE# 7% ENCORE POWDER FREE LATEX Product use: EO sterilization surgery convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF(10) Gauze sponge 4" X 4" 16PLY XRD LIF(5) LAP sponge prewash 18" X 18" XRD LIF( 1) LITE GLOVE LIF(1)) Pouch suture flower(1) Scalpel#1 0 Carbon steel(1) Scalpel#15 Carbon steel(1) YANKAUER suction tube without exhaust port(1) Cautery knife Head polisher (1) Glass pan (14) "X 90" L/F(2) Surgical drape 41" X 58" SMS(1) Laparotomy Surgical drape "T" 102" X 78" X 121" STD SMS (4) Surgical drape and tape LIF(2) Needle and blade Counter 10C MAG/CLEAR LIF(1) Tubular suction connector W'X 12' LIF(3) Absorbent towel 15" X 20" LIF(1) Burning pencil Button (1) IMPERVIOUS gown with additional reinforcement X-LARGE TOWEL Ill(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIFEO sterile surgical convenient packaging, packed in a polyester/polyethylene breathable bag with Tyvek double vents. Customized Determining different catalog numbers may affect the integrity of the package (a lot more). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – Open heart-shaped tray – Packaging A(1) CV split curtain with transparent EST screen STD SMS LIF(5) Curtain% ECONOMY 53" X 77" LIF(1) MAYO Support cover reinforced LIF(7) Curtain utility with tape L/F(8) Hackcloth towel white L/F(20) Hackcloth towel blue LIF(1) MAYO tray large LIF(1) Table cover BTC 77" X 110" HD full coverage LIF(6) 3/ 4 pieces of drape enhanced LIF(2) STOCKINNETTE 9" X 48" LIF(1) split piece bilateral 84" X 80" LIF(3) overhang piece 41" X 58" SMS LIF(4) Pr. Glove Surgeon #7 BIOGELOPEN Heart Tray – Hospital DAMAS – Packing B-(1) Plastic ruler 12" long (2) Syringe 60ml needle-free LISLIP L/F(1) Pk. Peanut Sponge Dissector ST.(2) WL. LIF(1) Skin marking LIF with ruler (2) Utility bowl 16 oz UF(3) Bulb syringe 60cc UF (1) MAYO TRAY small L/F(2) YANKAUER SUCT. Tube without ventilation UF (1) Tray Organ full depth LIF(5) vaginal vein cannula LIF (40) knee sponge pre-washed XRD UF(2) elastic bandage 6" X 5 yards. UF (2) Suture bag flower (2) Needle and blade counter 40c foam/MAG UF (1) Sharp blade ALL​​ ARROUND 69 (1) Surgical blade # 11 Carbon steel (4) LITE glove UF(2) # SURGICAL blade Steel (1) specimen container 4 oz. With lid and label (1) Syringe 1 cc TUBER 25G X 5/8 S/TIP LIF (2) Bag instrument (2) Surgical blade# 10 Carbon steel (30) Gauze sponge 4" X 4" 16-layer XRD UF( 2)) Burning pencil rocker switch life (2) Polishing agent burning tip UF (1) Label set; Heparin; Saline (2) Elastic bandage 4" X 5 yards. LIF (1) Watch cover BTC 77" X 110" HD Full coverage UF (1) Needle 18G X 1% LIF(2) Anti-adhesive gloves Heavy-duty (1) Aortic monitoring press kit 5.0(1) Connector Y 3/8" X 3/8" X 3/8" LIF (2) Needle 22G X 1% LIF(1) Blade 6.1 X 32.3 X 1.0MM (1) Square two PIECE 500cc GRADUATE(2) Connector reducer (1) Needle blade/knife 3.0MMEO Sterile surgical convenience package, packaging In a polyester/polyethylene breathable bag with Tyvek dual vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Umbilical Cord Vascular Catheter Kit-Customized-(1) Paper tape measurement display. 24 inches (1) window curtain 18 inches x 26 inches LIF (1) needle holder BAUMGARTNER 5 inches (2) HALSTED mosquito CVD 5 inches serration (1) ADSON FORCEP TISS. Wff(1) Syringe 3cc LIFLUER without lock) Gauze sponge 2" X 2" 8PL Y(6) GAUZE 4" X 4" 16PL Y(1) Syringe 1 cc TB SffiP(1) IRIS ForcEP SERR Y. CVD 4" Tip with protector (1) Needle with filter 18 X 1 Y. BLUNTffiP (1) Stitching 3-0 BLK single strand (1) Full depth of pallet organizer (1) Wrapping paper 30" X 30" L/F (1) PVP triple iodophor swab (1) Tongue depressor 6" wood (1)) Iris scissors straight 4 Y. Tip with protector (1) Scalpel with handle (1) 5" (2) with handle ) Syringe 5cc without needle LUER lock life (2) 3 layers of polyester towel (1) UMBIL 1) Probe ground and DISNEETNS 6" 2ML (1) Eye dressing EXT FINE POINT FULL (2) Needle with filter 18 X 1 Y. NOKOR PO(1) Plastic Tray 2/Compartment (1) Half Tray (1) WAYCOCK LUER SLIPEO Sterile surgical convenience bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has dete believes that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc" Customized-Orthopedics (1) Customized content: (1) Robe XL SMS IMPERVIOUS reinforcement (4) Drape practical WffAPE (1) MAYO support cover reinforcement (1) Suture bag flower (1) ) Overhanging top W/108" X 50"" STD SMS (1) DRAPE ORTHOPEDIC SPLIT(1) U-DRAPE 60"" X 70"" WffAPE SPLIT 6 X 21 (1) Countertop reinforced type 50"" X 90"" (1) Surgical gown reinforced XLGE TOWEL I WRAP (1) STOCKINETIE IMPERVIOUS 12"" X 48"" Product use: EO sterile surgical convenient bag, packaged into a polyester/polyethylene breathable bag with Tyvek double vents. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – Caesarean section package – – (1) MAYO support cover reinforcement LIF(20) Knee sponge prewash XRD LIF(1) Umbilical cord clip LIF(1) Cover plate reinforcement 50" X 90" LIF(1) Surgical DURAPREP solution 26ML LIF(1) BEANNIES BABY(1) Polishing head CAUTERY LIF(1) LITE GLOVE L/F(1) CAUTERY Pencil ROCKER SWITCH L/F(1) C-Section Drap with Pouch LIF( 1) MAYO TRAY SMALL(1)) YANKAUER straw without ventilation L/F(1) Blade Surgical #10 Carbon Steel(2) Bowl practical 32 oz. LIF(2) Pad Obstetrics X-Large LIF(5) Towel absorbent 15" X 20" LIF(1) Cover cloth 41" X 58" SMS LIF(1) Tube suction connection. Y.." X 12' LIF(1) Ear Ulcer Syringe 2 oz. LIF(2) GOWM Water-impermeable Extra Reinforcement X Large(1) Receiving Blanket 100% Cotton (2) Needle and Blade Counter 1 Oc MAG/ Convenient packaging customization of CLEAR surgical LIF packaged in a polyester/polyethylene breathable bag with Tyvek dual vents. The company has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may be due to The product is contaminated or loses its sterility.

Customized on August 29, 2014; Inc "Customed – Minor EXTREMITY PACK {2)CUSTOMEDCONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1) TOWELS ABSORBENT 15"" X 20""(1) MAYO STAND COVER REINFORCED (1) SHEET PLASTIC 44 "" X 65""(1) Drape% ECONOMY 53"" X 77"" (1) Drape utility tape (1) Bag seam lace (1) Sheet end ABS 125"" X 85"" SMS(1) Form COVER REINFORCED 50"" X 90""(1) GOWN XL SMS IMPERVIOUS REINFORCED Product use: EO sterilization surgery convenient bag, packaged in polyester/polyethylene with Tyvek double vents In a ventilated bag. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "customized-open heart-shaped pallet packaging: (1) table cover BTC 77"" X 110"" HD full coverage life (1) MAYO bracket cover reinforced L/F (3) towel Absorbent 15"" X 20"" LIF( 1) Cover reinforcement 50"" X 90"" LIF (1) Split double-sided 84"" X 80""(12)% Sheet 60"" X 77"" Drape reinforcement LIF (1) MAYO tray large (1) CV DRAPE SPLIT CARDIO WITH CLEAR AEST. SC STD SMS (15) Towel Bukhak Blue (4) Towel Bukhak White (2) STOCKINETTE IMPERVIOUS 14"" X 48" "LIF (30) Knee sponge prewash 188"" XRD LIF (1) Package 54"" X 54""(3) LITES GLOVE LIFOPEN HEART TRAYHOSPITAL HERMANOS MELENDEZPACKB Content: (1) Table cover BTC 77"" X 110" "HD full coverage LIF(1) 4oz container with sample. Lid and label(2) catheter thoracic cavity 32FR. Straight(2) pencil cauterization rocker switch LIF(3) tube suction connection WX 12' LIF(2) syringe 20cc without Needle LUER lock LIF (1) HEPARINE label set; CAUTERY tip polisher LIF(1) Table cover reinforcement 50"" X 90"" LIF (1) Bandage elasticity 6"" X 5yds LIF(2) YANKAUER straw, without row Air LIF (2) Syringe 10cc without needle LUER lock LIF (1) Needle 25G X 5/8 ST. (10) Gauze sponge 4"" X 4" LIF 1) Needle injection 27G X %"" ST.(1 ) Needle and blade counter 60C MAG/MAG (2) BOWL UTILITY 16oz. (4) Feeding tube 8FR; 15"" long (2) Bulb syringe 60cc (1) Large tray platform (1) Skin marker with ruler (1) ) Catheter 18FR Straw W/STRA LIF (1) Package 54" X 54"" UF(1) Scalpel #10 Carbon steel (1) Surgery blade #15 Carbon steel (2) Surgery blade #11 Carbon steel (1) Blade Surgery #20 Carbon steel heart-shaped tray hospital HERMANOS MELENDEZPACKCCONTENTS(10"X"5" 6) GOWN FAB REINFORCED SO NTARA X-LARGE(1) GOWN IMPERVIOUS XTRA REINFORCED X-LARGE TOWEL & WRAP LEVEL Ill(1) Table cover reinforcement 44"" X 78"" UFProduct Usage: EO sterilized surgical polyester/polyethylene packaging with Tyvek double ventilation The breathing bag of the mouth. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized Inc-Laparoscopic Gallbladder Bag-(4) Draping utility with tape LIF (2) Absorbent towel 15" X 20" LIF(2) Robe IMPERVIOUS Extra reinforcement X Large LIF(1 ) Surgical DURAPREP solution(16) TIF set 81"2.1M Common clam ST.(1) Scalpel laser camera with 6" X 96"(1) Laparoscopic abdominal scalpel with L/F(1) Table cover 44" X 90"(1) MAYO Stent Reinforced L/F(1) Surgical Blade# 11 Carbon Steel (1 0) Gauze Sponge 4" X 4" 16PL Y XRD LIF(1) Tracheal inflation device with 0 ring adapter L/F (1) Tube suction connection W'X 12' LIF (1) TROCAR Endopath XCEL Expansion Tip 5MM (K5LT) LIF (1) CEF AZOLIN Red Label (1) Gentamicin Green Label (1) AZUL DE METILENO Label (1) ) Heparin White Label (1) Lidocaine is packaged in a polyester/polyethylene breathable bag with Tyvek double vents for surgical convenience. The customer has determined that the package integrity of different catalog numbers (multiple batches) may be affected Impact. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – ARTHROSCOPY PACK- (1) Video camera curtain 13cm X 244cm LIF(2) Elastic bandage 6" X 5yrd. LIF(1) U-shaped curtain 60" X 70" with tape Bifurcation (1) DURAPREP SURGICAL SOLUTION 2 (1) STOCKINETIE IMPERVIOUS(1) Tubular Suction Connector. 3/16" X 12' LIF(1) Sheet Arthroscopy T STD SMS Bag LIF(1) Bag Suture Flower LIF(1) Blade Surgery #11 Carbon Steel(2) GOWN IMPERVIOUS EXTRA REINFORCED X-Large LIF(1) Syringe 30cc SLIP TIP LIF(1) Table Cover 44" x 90"(1) MAYO Support Cover Reinforced LIF(4 ) Towel absorbent 15" X 20" LAP LIF(1) Pre-wash XRD UF(1) Suspended piece 41" x 58" SMS UF(1) Needle 22G X 1 Y:z(1) Needle 18G X 1 Y:z (1) Syringe 10cc without needle (LIF lock) 10) GAUZE SPONGES 4" X 4" 16PL YEO sterile surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Advanced Ophthalmology Packaging-Customized-(1) Dress SMS X Large Standard Raglan Type (1) Cup of Medicine 2 oz (1) Drape Ophthalmology. Bag LIF(1 0) Sponge eye spear MICRO(1) General purpose goggles(6) Cotton tip application 6" Wooden LIF(1 0) Gauze sponge 4"X 4" 12PL Y(2) Towel absorbent 10" x LIF(1) Cover MAYO Support reinforcement LIF(1) Syringe 1 ML without needle LUER Lock LIF(1) Cover reinforcement 50" x 90" LIF(1) Syringe 3cc with needle 21 GX 1% LIF(1) SMS G The non-strengthened towel/WRAPEO sterilization operation is convenient to pack, packed in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause injury to the patient due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – LAPAROSCOPY GYN PACK – – (1) BLADE SURGICAL #11 Stainless steel (4) Hanging utility tape LIF(2) Absorbent towel 15" X 20" LIF(1) GOWN IMPERVIOUS REINFORCED 11 LARGE TOWEL blue (1) blade scalpel #15 carbon steel (2) utility bowl 16oz(1) utility bowl 32oz(2) leggings with 7" cuffs 30" X 42" LIF(1) EMESIS basin 10 inches 700cc Camera (13) X 244cm LIF(1) MAYO bracket cover reinforcement LIF(10) Gauze sponge 4" X 4" 16PLY XRD LIF(2) Pipe suction connection 114" X 12' LIF(1) Table cover reinforcement 44" X 78 ") Hang the knees. PERINEAL 102" X 97" with POUCH(1) GOWN SURGICAL SURGICAL SURGICAL SURGICAL SUGICAL REINFORMED large towel/WRAPEO sterile surgical convenient bag is packed into a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-PERY GYN bag-(1) Table cover reinforcement 44" X 78" UF (2) Towel absorbent 15" X 20" LIF (2) Robe large SMS impermeable reinforcement (1) ) 16 ounces with pouch (1) on the bottom of the folds. (10) Gauze sponge 4" X 4" 16PL Y XRD UF (1) ROBNEL catheter 18FR. (1) DRAPE SHEET 41" X 58" SMS(2) LEGGINS 30" X 42" with 7" cuffs Customization with Tyvek double vents has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Main Knee Packaging-(1) Table cover REINF. 50" X 90" 10) GUZE sponge 4" X 4" 16PLY XRD(1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) Practical bowl 32oz(1) pipe joint. Suction power WX 12' (1) CAUTERY TIP POLISHER(1) YANKAUER straw with 0 vent (4) Draping utility tool with tape (2) Lens hood (1) MAYO bracket cover reinforcement (4) Absorbent towel 15" X 20" (2) Drape sheet Piece 58-inch SMS(2) Needle and Blade Counter 1 Oc Magazine/Clear(2) Robe XL SMS IMPERV. Enhanced (1) Stitched Bag Flower (1) Timeout Beacon Non-woven Fabric (5) Knee Sponge Pre-wash 18 inches X 18 inches XRD (1) SKIN MARKER W/8/LABEL/TIME OUT/RULEREO Sterile surgery convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customd has confirmed different catalogs The number(s) may affect the integrity of the package due to product contamination or loss of sterility, which may cause injury to the patient.

Customized on August 29, 2014; Customized by Inc-CYSTO TUR PACK- -(1) Practical bowl 32 oz LIF(1) Sample cup with lid 4 oz LIF(1 0) Gauze sponge 4" X 4" 12PL Y LIF( 4) Absorbent towel 15" X 20" LIF( 1) CYSTOSCOPY'T' DRAPE 60" X 87" X 35" SMS STD LIF(2) Extra reinforcement for impermeable robe X Large LIF(2) Tight fit with 7" cuffs Pants 30" X 42" LIF(1) Table cover 4 Reinforced" X 78" LIF(1) Cover with bag 44" X 35" LIF(1) Syringe 60ML SLUER SLIP Without needle LIF(1) TUY Set of 81 "2.1 M ordinary clams (4) gauze sponge 4" 12-layer XRD L/FEO sterilized surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined different catalog numbers ( Multiple batches) packaging integrity may be affected. This may cause injury to the patient due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – ORTHOPEDIC IMPLANT PACK CUSTOMED USA; CODE 900-2903CONTENTS:(1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER(1) BAG SUTURE FLORAL (1) U – DRAPE 60"" X 70"" split type 6"" X 21""(1) Pipe suction connector W'X 12' UF (2) Abdomen pad 8"" X 7.5""(1) Bag glass (1) YANKAUER Suction tube W/0 VENT LIF (2)) LITE GLOVE UF (1) SOLUTION SURGICAL DURAPREP 26ML LIF (2) Reinforced operating table cover 50"" X 90"" LIF (1) Surgical blade #10 stainless steel (1) MAYO Support Cover Enhanced LIF (1) ADHES 108"" X 77"" STD SMS L/F (5) Towel absorbent 15"" X 20"" UF (1) STOKINETIE IMPERVIOUS 14"" X 48"" LIF( 2) Overhang piece 70"" X 100"" LIF (1) *Gloves# 7′! h SURGEON NEUTRALON LATEX (5) LAP Sponge PREWASH 18"" X 18"" XRD LIF (1) *GLOVE # 8 SURGEON NEUTRALON LaTEX (1) SKIN STAPLE 35 WIDE WIDE UF (1)) *Gloves# 8 feet! h SURGEON neutral latex (1) Tray MAYO LGE (1) GOWN SURG REINFORCED XL T OWEUWRAP (1) Hanging coat with adhesive 108" "X 50"" STD SMS UF (2) GOWN XL SMS IMPERVIOUS Reinforced UF (1) bulb syringe 60cc transparent (1) CAUTERY PENCYL ROCKER SWITCH ILITY UF(1) (1) BLADE SURGICAL# 20 stainless steel (1) UTILITY BOWL QUART 32oz LIF (4) DRAPE UTILITY WITAPE UF(1) DRAPE INCISION 23"" X 17"" UF product use: Polyester/polyethylene breathing bag with Tyvek double vents for convenient packaging of EO sterilization surgery. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Plastic Packaging Customized; Code 900-2582(1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF LGE TMJRAP LIF (1) MAYO Stand Cover REINF LIF (1) Table Cover REINF 50" X 90" LIF (4)(1) PVP Paint 8" Sponge Stick (2) Curtain Cloth 41X AMED LIF(3) Towel Absorbent 15 X 20 LIF(2)DRAPE UTILITY Rape LIF(1) BLADE SURGICAL15 S/STEEL (10) GAUZE SPONGE 4 X 4 16 PL Y(20) APPLICATOR COTOIN 6 WOOD Product use: EO sterilization surgery convenient bag, packaged in poly Tyvek double vents in the ester/polyethylene breathable bag. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause product contamination or loss of sterility to the patient harm.

Customized on August 29, 2014; Inc. "Customized-Neurospine Pack Content: (1) Suture Bag Flower LIF (1) Needle and Blade Counter SOC Foam STR//MAG STR (2) Cover Table BTC 77"" x 110" "HD Full Coverage LIF (4) Draping utility with tape LIF(1) piece'I"" 60"" X 77"" DRAPE REINF. LIF(2) Specimen container 4 ounces with lid and label (2) Cup of medicine 2 Ounce UF(2) tube suction connection v.” X 12' UF (2) Skin marking ink with 8 labels (20) Gauze sponge 4"" X 4"" 16ply XRD UF(5) Sponge LAP PREWASH 18"" X 18"" XRD UF (2) Syringe 20cc W/ 0 NDL LILOCK ST.LIF(1) YANKAUER SUCT.TUBE W/0 VENT LIF(1) DRAPE INCISE Antibacterial Agent 23"" X 17"" LIF (1) Polishing Burner tip LIF(2) Pencil burning manual switch LIF(1) DRAPE T LAPAROTOMY 102"" X 78"" X 121"" STD SMS LIF (1) GOWN SURG Reinforced large towel wrap (2) Blade SURG #15 Carbon Steel (1) PK.STRIP SURGICAL %"" X 6" COTTON (1) PK.STRIP SURGICAL Y4"" X 6"" Cotton (10) Gauze sponge 4"" X 4"" 16ply(1) Needle 20G X 1 % (1) Washbasin 6qt(4) Cloth towel 42 "" X 57"" SMS LIF(2) DERMABOND HV Local skin ADH (1) BOWL UTILITY 32oz.(2) Syringe ear/ulcer 2oz LIF(2) Blade extension electrode (2) Solution DURAPREP (16mL) Electrode needle 1 inch W/TIP protector (1) With surgical'I""X 6""(2) GOWN XL SMS IMPERV. Enhanced UF(1) Rope bipolar FIRCEPS( 4) Terry cloth HUCK (white) (2) Dressing OpSITE POST PO 2%"" x 2"" (2) Bagged instrument 7 X 11 (1) MAYO tray large (1) MAYO STAND COVER REINFORCED UFProduct: EO Convenient packaging for sterilization surgery, packaged in a Tyvek double vent In a polyester/polyethylene breathable bag. "The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may result in harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Dress Cool Impervious XLGE breathable customization; 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) Wrap 24" X 24" (1) Towel absorbent 15" X 20" LIF product use: Convenient packaging for EO sterilization surgery, packaged in a polyester/polyethylene vented bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – Angiography Package--(4) Buhak towel blue UF(1) Table cover reinforced 50" X 90" LIF(1) Syringe 20cc Needleless Luer Lock UF( 2) Medicine cup 2 ounces. LIF(3) Practical bowl 32 ounces UF(1) Vomit basin 10 inches 700 ml(4) Towel clip(3) Absorbent towel 15" X 20" LIF(1) Syringe 3cc without needle LUER lock L/F(1) Tobacco 1) PVP SCRUB 8" stick sponge (1) Tray platform large (3) Skin marking label (1) Medicated saline normal blue label (1) Medication TRIDIL VIOLETA label (1) Needle injection 14 hours 18 hours) Syringe 10cc without needle LUER lock LIF(1) 30cc syringe without needle LUER lock LIF(2) utility bowl 16oz(3) drawstring bag with blanket and tape LIF(25) gauze sponge Y4" LIF 16" XPL DRAPE ANGlO 75" X 145"(1) Needle 21 GX 1'h LIF(1) Safety scalpel #11 LIF(1) Robe standard SMS large Velcro neck (2) Needle 23G X TRAYFULL deep(1) Robe large Non-reinforced SMS towels and wrappers (1) Medical micaine label yellow (1) Medical contrast agent green (1) Medical label INTEGRILIN red (1) PVP paint 8-inch packaging for easy access to polyester/polyethylene It has been determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Liposuction Pack MRT; Code 900-2656; Contains: (1) Needle 27 X 1 LIF (1) Practical bowl 4 quarts 32 oz LIF (1) MAYO bracket cover reinforcement LIF (2) GOWN SOFT SMS STD X large sleeve sleeve LIF (1) PVP scrub solution (4oz) 20) gauze sponge 4 X 4 (12) towel cloth clip (blue) (4) towel clip (3) suction Head absorbent applicator viscose sponge life(1) Safety scalpel 15(3) Overhanging piece 70 X 200 Towel (LIF) 15 X 20 LIF(2) Reinforced table cover 44 X 78 LIF(1) Skin marking ink with 8 Labels/timeout/ruler LIF(1) 8 oz denture cup with lid(2) Syringe 10ml with fixed M/L dark green(1) Pipeline peristaltic pump(2) LITE gloves L​​/F Product use: EO Convenient packaging for sterilization surgery, packaged in a polyester/polyethylene vented bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – Bandeja para Debridacion; Code 900-2702; Contains: (1) FORCEP ADSON TISS (20) Gauze sponge 4 X 4 12PL Y (1) SCISSORS IRIS STRAIGHT 4.5 W/Protecter TIP( 1) TOWEL 3 PLY POLY 13 X 18(1) DRAPE 18 X 26 WHITE/WHITE (1) CHLORASCRUB SWABSTICK 1.6 ML(1) TRAY KUTIER(1) SCALPEL W/HANDLE 20(1 i WRAPPER 24 X 24 Product Usage: EO disinfection Surgery convenient packaging is packaged into a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may be due to product contamination or sterility The loss of the patient will cause harm to the patient.

Customized on August 29, 2014; Customized by Inc – NEURO PACK- (1) Table cover 44" x 90"(1) Surgeon-reinforced oversized scarf (1) IMPERVIOUS robe, reinforced oversized SMS(1) Bag stitched flowers ( 1) MAYO support cover reinforced type (2) Absorbent towel 15" X 20" LIF (4) Practical hanging with tape LIF (1) U-shaped hanging 60" X 70" with tape bifurcation (1) Leakproof 14" X 48" L/F(1) Split type with adhesive 1 08" X 77" STD SMS LIF(1) Top overhang with adhesive 1 08" X 50" STD SMS L/FEO Convenient aseptic operation Packed in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – TRAATEK NEURO PACK(4)TOWEL ABSORBENT 15" X 20" LIF(1) MAYO STAND COVER REINFORCED LIF(1) CAUTERY TIP POLISHER LIF(8) TOWEL CLOTH HUCK (BLUE)( 1) BULB SYRINGE 6) Meter cover BTC 77" X 110" HD full coverage (2) LITE gloves (1) pipe suction connection. Y.." X 12' LIF( 1) Skin marking ink with 8 labels/timeout/ruler LIF( 1) Overhang% ECONOMY 53" X 77" LIF( 1) Paging with adhesive 77" x 146"( 2 ) GOWN XL SMS IMPERVIOUS REINFORCED LIF(2) Syringe 60ml without needle LUER LOCK LIF(1) Syringe 20cc without needle LUER LOCK LIF(1) STAPLE SKIN 35 Wide life(1) LIGHT LIFE 2 LIFFER LIF Syringe LIF(1) SOLUTION SURGICAL DURAPREP 26ml LIF(1) Pk. NEUROPATTIES 0.45MM 10ea/pk(1) Pk. NEUROPATTIES 0.35MM 10ea/pk Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Carpal Tunnel Surgery Large Package (1) Cover 44" X 90" LIF(1) Needle HYPODERMIC 18G X 1% LIF(1) Syringe 10cc Needleless LUER Lock LIF(1) A 32-ounce bowl is practical. Sheet 41" X 58" SMS LIF(2) Towel absorbent 15" X 20" LIF(1) Bandage gauze elasticity 4"(1) Needle 25G X 5/8(2) Scalpel #15 Stainless steel (stainless steel) towel cloth HUCK Blue LIF(1) Filled cast cotton roll 2" X 4yds(1) STOCKINNETTE 6" X 48" L/F(10) Gauze sponge 4" X 4" 16PLY XRD LIF(4) Drape practical LIF(1) dress Operation. Fabric reinforcement X Large AAMI Ill LIF(1) Timeout beacon non-woven fabric(1) Hand towel ORTHOARTSO 76" X 150"(1) Anti-needle and blade 20C foam/MAG L/F(1) Skin marking ink label/timeout / Ruler (1) Bag stitched flower L/F(1) Extra reinforced large towel for impermeable robe/wrap L/FEO Sterilization operation convenient bag packaged into polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customized-Laparoscopic Colorectal Surgery Package Content: (1) Solution DURAPREP 26 ml LIF (4) DRAPE UTILITY with TAPE LIF(3) TOWELS ABSORBENT 15"" X 20"" LIF (2) LEGGINS W/7"" X 42"" LIF(1) Scalpel #15 stainless steel (1) Scalpel #11 stainless steel (1) Robe IMPERV. Extra reinforcement. XLG AAMI Ill LIF(1) Irrigation straw TROMPET Double-pointed bayonet LIFE 4"" X 4"" 16PLY XRD LIF(2) Practical bowl 16oz. LIF(2) PK. STERI STRIP CLOSURE%" X 4"" L/F(1) ACTIFOG with foam pad solution LIF ( 1) Table cover reinforcement 50"" X 90"" LIF (1) MAYO support cover reinforcement LIF (1) Needle ULTRA VERES 120MM LIF (1) STAPLE hinged trapezoid 60MM LIF (1) Reload white 60MM ECHELON L/F(2) ) XNCELIFE 5 (1) TROCAR 5MM blade, barbed cannula UF (1) TROCAR 12MM blade, barbed cannula LIF (10) Knee sponge prewash 18"" X 18"" XRD LIF(1) tube inflation device, with 0 Ring adapter F (2) LITE gloves (1) Pencil type cauterization rocker switch with holster LIF (1) Electrode double decompression (1) Laparoscope/lithotomy drape with transparent instrument bag (1) Counter NDLE/ Blade 20C Foam Marker (1/MAG) Ink Band 8 Label/Timeout/Roller Life Cycle (1) Overlock Flower (1) Robe IMPERV Super Reinforced Large Towel and Package Life Cycle (1) Polishing Agent Burning Tip Life Cycle (1) Pack glass oil (1) Reload blue 60mm life cycle (1) TIME OUT BEACON non-woven LIF Product use: EO sterilization surgery convenient bag, packaged in polyester/polyester with Tyvek double vents In a ventilated vinyl bag. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customized-Laparoscopic Biliary System PACKMIAMI METROCON Tent: (12) Terry cloth HUCK BLUE LIF (1) MAYO support cover reinforcement LIF (1) Table cover reinforcement 50"" X 90"" LIF (1) Suture bag (10 flower L)) gauze sponge 4"" X 4"" 16PLY XRD LIF (1) bulb syringe 60cc LIF (1) blade surgery #10 stainless steel (2) piece% 60"" X 77"" Suspended reinforcement LIF SPONGE (10) 18"" X 18"" XRD LIF(1) Scalpel #15 Carbon steel (1) Pipe suction connection Y."" X 12' LIF (1) Bag glass plain weave (1) Burning tip Polisher LIF(1) Hanging knees. Abdominal belt pocket 102"" X 122"" X 78"" LIF (1) PK. STRIP STERI closed W'X 4"" LIF(1) Skin marking ink with 8/ Label/timeout/ruler L/F (1) Rope-type laparoscopic unipolar food switch (1) Anti-needle blade 30c magazine/foam (1) Timeout beacon non-woven fabric LIF (1) Robe XL SMS Water impermeable reinforcement life (1) Robe surgery/reinforcement 1 reinforcement TOG) Towel absorbent 15"" X 20"" LIF(1) Surgical blade #11 carbon steel(1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1) YANKAUER OPEN TIP CLEAR without C IV LIFATTACHED PACK with the following STERILE component: (1) ACTIFOG WITH/FOAM PAD SOLUTION LIFProduct Usage: EO sterilization operation convenient vinyl breathing bag, with polyester/polyethylene packaging Tyvek double vents.” Customed has been confirmed, different The packaging integrity of the catalog number (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customized-Neurospine Pack; Code 900-2765 Content: (l) DRAPE INCISION 23"" X 1 7"" (I) SCALPEL W/handle # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W'X 6""(I) CAUTERY Pencil Hand SWITCHING LIF (4) Practical surgical drape with tape L/F(I) scalpel with handle# 10 S/Steel (I) Tubular Suction Connector W'XI 2'LIF(I) Skin Marking with Ruler (2) Specimen Container 4 oz with Lid and Label (I) Solution DURAPREP 26 ml LIF (I) YANKAUER Pump Suction tube with 0 exhaust port LIF(I) MAYO tray lager) Needle and blade counter 10c MAG/CLEAR (I) DRAPE INCISE Antibacterial agent 23"" X 1 7"" LIF (2) Syringe I Occ W/0 NEEDLE LUER LOCK LIF (I) J VAC reservoir 300ML (2) LIF GLOVE (2) CAUTERY TIP POLISHER LIF (2) Table cover BTC 77"" X 110"" HD FULL L/F (20) Gauze sponge 4"" X 4"" 16PLY XRD LIF (4) Towel absorbent 1 5"" X 20"" LIF(I) Drape T Laparotomy 102"" X 78"" X 1 21"" STD SMS (5) LAP SPONGE PREWASH 18 "" X 18"" XRD LIF (I) Stitched bag flowers (5) Draping'l'4 ECONOMY 53"" X 77"" LIF(3) Extra REI NF for impervious robe. LGE T/WRAP (I) UTILITY BOWL 1 6oz LIF Product use: EO sterilization surgery convenient packaging, packaged in a polyester/polyethylene vented bag with Tyvek double vents." The customer has determined that different catalog numbers may affect packaging integrity (multiple batches ). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc" Customized – TLIF PACK Surgery Center; Code 900-2918. Content: (2) Solution DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF (4) GOWN SOFT SMS STD XLVE set(4) Towel ABSORBEN 15"" X 20"" LIF(1) Table cover reinforcement 50"" X 90"" LIF (1) MAYO Stand cover reinforcement LIF (4) DRAPE% 60"" X 76 "" Strengthen L/ F(1) DRAPE CHEST 100"" X 142"" X 72"" LIF(1) FLUORO COVER 30"" X 30"" with RUBBBAND ​​LIF (2) LITE GLOVE LIF(2) TUBE SUCTION CONNECT .Y."" X 12' UF (12) Towel Buhak Blue LIF(1) Practical Bowl Quarter 32 oz (10) Gauze Sponge 4"" X 4"" 16PLY XRD UF(5) Knee Sponge prewash 18"" X 18"" XRD LIF 1) CAUTERY pencil rocker switch with holster LIF (1) STERI strip hanging large 17"" X 23"" LIF (1) skin marking, with ruler UF (9) Skin marking label 1.25 X Y2 (1) Ruler (1) & Blade counter 20C FOAM/MAG L/F (2) Syringe 20cc without needle LUER lock LIF (2) Syringe 10cc without needle LUER lock LIF (1 ) Bulb syringe 60cc LIF(4) Needle 8GDER X 1Y2 UF(1) Needle 22G X 1Y2 LIF(2) Syringe 3cc without needle LUER lock UF (1) Needle spinal cord 18G X 6"" long life(1) Blade surgery# 10 STEEL CARB CARB 15 Carbon steel (1) Time-out beacon non-woven fabric (2) Dressing TEGDERM 4"" X 4% ""UF (2) MEDICINE CUP 2oz(1) DRAPE IOBAN INCISE 2 Antibacterial 23"" X 23" "LIF product use: EO sterilization surgical convenience package, packaged in a polyester/polyethylene vented bag with Tyvek double vents." Customed has determined that the package integrity of different catalog numbers (multiple batches) may be affected. affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Laparoscopic Gallbladder Bag-(1) Pendant laser camera with elastic 6" X 96" LIF (2) Single hanging 42" X 57" SMS(1) Tube suction connection. %" X12' LIF(1) Surgical blade #10 stainless steel(1) Reinforced table cover 44" X 78" LIF(1) Pendant laparoscope. ABD 102" X 122" X 78" with bag(5) Knee sponge XRD PRE L/F(1) Needle Injection 18G X 1%"(1) MAYO Support Cover Reinforced LIF(1) Practical Bowl 32 oz L/F(1) Tube Inflation Kit W/0 Ring Adapter LIF(4) Towel Absorption 15" X 20" L/F(1) Container Specimen 4 oz with lid and label(1) Buhak towel blue L/F(1) PVP paint 8" stick sponge(4) Draping utility with tape LIF (2) Utility bowl 16 oz LIF (1) Syringe 20cc needle-free LUER lock LIF (1) PVP frosted 8" stick sponge (1) Clip ligation TIT M/L (LT 300) (4) TEGADERM 2 3/8 X 2% L/F(4) GOWN SURG. Reinforced large towel/WRAPEO sterilization operation convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined different catalog numbers (multiple batches) The integrity of the packaging may be affected. This may cause harm to the patient due to product contamination or loss of sterile conditions.

Customized on August 29, 2014; Customized by Inc-Caesarean section package-(1) MAYO support cover enhanced life cycle (5) Towel absorptive life cycle (1) Robe X large SMS IMPERVIOUS enhanced L/F (3) Curtain fabric 41" X 58" SMS LIF(1) Baby blanket printing LIF(1) Bowl plastic 80 ounces, with cover (1) tube suction connector. %" X 12' LIF(15) Knee sponge prewash XRD LIF(1) Ear ulcer syringe 2 ounces. LIF(1) pad obstetric X large ST. L/F(1) YANKAUER straw without exhaust L /F(1) Syringe 20cc SITIP LIF(1) Feeding tube 8FR. 15" long(1) Baby bean LIF(1) Dressing table 4" X 14"(1) Hanging laparotomy belt bag 102" X 121" X 78" (1) GOWN SURG. Reinforced XLGE towel/wrap(1) Table cover reinforced 50" X 90" L/F(2) Needle and blade counter 10C MAG/CLEAR LIF(1) Suture bag flower LIF(1) Umbilical cord clip (1) Blade Surgery #20 Carbon Steel (1) Package 24" X 24" L/FEO convenient packaging for sterilization surgery, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that the package is complete. The possibility of sexual impairment is shown on different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Urology bag-(3) Towel absorbent 15" X 20" UF (1) Washbasin round 6QT. (1) Syringe 30cc W/O needle LUER lock UFN (1) ) Bag-type urethral drainage agent 2000 ml reflux solution (1) package suture flower (1) dress SURG. Enhanced X Large T/VIJRAP(1) Table cover 44" X 90" UF (2) Suspended piece 42" X 55" SMS UF(1) Pipe suction connection. Y." X 12' UF (1) MAYO Support Cover Reinforcement UF(10) Gauze Sponge 4" X 4" 16PLY(1) Robe X Large SMS Impermeable Reinforcement (1) Specimen Container 4 oz. With lid and label (1) ) TUR Y SET 2 LEAD ST. UF(1) DRAPE LITHO 110" X 63" SMS WITH LEGGINSEO Convenient packaging for sterilization and surgery, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has confirmed that the packaging exists Possibility of completeness. Product catalog numbers are different (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – OPHTALMIC PACK – (1) GOWN LGE SMS NON REINF TIWRAP (1) Iodopovidone 1oz. (2) Towel absorbent 15" x 20" UF (1) Syringe 3cc with Needle 21 GX 1 Y. UF(6) COTION tip applicator 6" wood (1) table cover reinforcement 50" X 90" UF(1) eye pad 2 1/8 X 2 5/8 (1) CYSTOTOMO IRRIG. PEARCE 25G X 5/8(1) SHIELD EYE UNIVERSAL (1) Pr. Gloves SURG.# 7% latex(10) Sponge eye spear micro(1) Syringe 1cc tube. 25G X 5/8 SITIP UF(10) Gauze sponge 4 "X 4" 12PL Y (1) Pr. Gloves SURG. 8 Powdered Latex (1) MAYO Support Cover Reinforced UF (1) Blade 15D with Handle (Knife) (1) Eye Mask (1) Long Gown Standard SMS (1) ) Tray 3/COMPART (1) Bag zipper lock (1) Angled full handle (1) Pr. Gloves SURGICAL# 6% LATEXEO sterile surgical convenient packaging, packaged in polyester/polyethylene with Tyvek double vents In a ventilated bag. The customer has determined that different catalog numbers may affect the integrity of the package (multiple batches). This may cause injury to the patient due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-ARTHROSCOPY Bag- (1) Table cover reinforcement 50" X 90" (1) Pre-pad with cuffs (2) Robe XL SMS IMPERVIOUS reinforcement AAMI Ill (1) Robe IMPERV. Additional reinforced LGE TNVRAP (1) MAYO bracket cover reinforced (1) pipe suction connection. X" X 12'(1) STOCKINETTE IMPERVIOUS 14" X 48"(1) U-DRAPE 60" X 70" with TAPE SPLIT 6" x 21"(1) Sheet arthroscopy "T"W/POUCH STD SMS( 1) Suture bag flower (3) Absorbent towel 15" X 20" EO sterilized surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined different catalog numbers (multiple) The integrity of the package may be affected due to product contamination or loss of sterility, which may cause injury to the patient.

Customized on August 29, 2014; Customized by Inc-Hip Joint Orthopedic Package-(1) Blade Surgery #15 Stainless Steel/Steel (1) Robe XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) Table cover reinforcement 50" X 90" LIF( 1) MAYO support cover reinforcement (1)) DRAPE Utility WIT APE LIF(4) Towel absorbent 15" X 20" LIF(1) YANKAUER straw, no exhaust LIF(2) Suspended piece 41" X 58" SMS LIF( 1) Needle and blade counter/20MAG LIF (10) Gauze 4" X 4" 4PLY(2) Practical bowl 16 oz LIF(1) Cautery head polisher LIF(1) Suture bag flower(1) Surgical blade #10 stainless steel( 1) SURGICAL DURAPREP 6m solution! LIF(1) specimen container 4 ounces. With lid and label (10) gauze sponge 4" X 4" 16PLY XRD LIF(5) Knee sponge prewash 18" X 18" XRD LIF(1) Cautery pencil rocker switch LIF(1) tube suction connection. 3/16" X 12' LIF(1) Antibacterial overhang cutout 23" X 33"(2) Single overhang 70" X 100" LIF(1) Overhang top with adhesive 108" X 50" STD SMS LIF(1 ) Single-split WITH ADHESIVE 108" X 77" STD SMS L/FEO sterile surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined different catalog numbers (multiple batches) ) Packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Internal Vein Customized Package-Customized (1) Syringe 5cc Needleless LUER Lock L/F(1) Pr. Gloves SYNTEGRA CR # 7.5 P/F LIF(2) Pr. Gloves SYNTEGRA CR # 6.5 P/F LIF(20) Gauze sponge 4" X 4" 12PL Y LIF(3) GOWN SMS X-Large STD Non Reinforced(1) Table cover 44" X 90"(4) Practical curtain, with Tape L/F (1) Denture cup with lid (1) Practical bowl 16 oz. (2) Counter needle and blade 10c MAG/transparent L/F (4) Rubber tape (1) Needle 27G X 1 Y.."( 1) Split sheet with adhesive 108" X 77" STD SMS LIF( 3) Nurse cap 21" green fluffy (3) Face mask surgical blue 120 mm HG LIF (1) Preparation pad with cuffs (2) Suction tip. application. Stick sponge L/F(1) SCALPEL weighing safety #11(1) Probe cover ST 6" X 96" Gel-free LIF(1) Package 30" X 30"(3) Towel absorbent 15" X 20" L/F product use: EO sterilization surgery convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – LABOR & DELIVERY PAC – 1) Needle HYPODERMIC 18G X 1% ST. (2) Hip drape with pouch (4) Towel absorbent 15" X 20" (1) Feeding Tube 8FR; 15 inches long (1) Peas baby (1) Syringe 20cc without needle LILOCK (1) Umbilical cord clip ST. (1) Receiving blanket 100% cotton (1) Towel cloth (blue) (2) WFFCUGG 30" X 42"( 1) Baby blanket 30 X 30 Poly ABS IMPERV. (1) Bowl plastic 80 ounces (1) Bowl lid 80 ounces transparent (20) Gauze sponge 4" X 4" 16PLY(2) Rubber pad ST. (1) Packaging vagina XRD 4 X 36 8PLY( 1) Table cover reinforcement 50 "X 90"( 1) Cover the abdomen with tape 40" X 54"(1) Needle 21G X 1% ST.(2) 10cc needle-free Luer lock(2) PVP scrub 8" stick sponge ST.(1) Ear Ulcer Syringe 2oz.(1) Dress X Large SMS Impermeable Reinforcement(2) Package 30" X 30"(18") P STICK SPONGE ST.(2) GLOVE SURG DERMA PRENE #7% PF(1) TIME OUT BEACON non-woven fabric ST. (1) VACUTAINER GREEN NAHEP 10MLEO sterile surgery convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents, it has been determined that there is a possibility of damage to packaging integrity sed in different On the catalog number (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – CYSTOSCOPY PACK Ill (1) (2) CUSTOMEDCONTENTS: (1) Table cover reinforcement 44"" X 78"" (2) Towel absorbent 15"" X 20""( 2) Tights with 7"" cuffs 30"" X 42""(1) DRAPE CYSTOSCOPY T 60"" X 87"" 35"" SMS STD(1) GOWN SURG.REINFORCED XL EXTRA LONG LEVEL IV Product use: EO sterilization surgery is convenient to package, packaged in a polyester/polyethylene respirator bag with Tyvek double vents.” Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Universal Package II (2) Customized 900-2509 (1) MAYO bracket cover reinforcement (2) Hanging side 42" X 76" with tape (1) Hanging bottom absorption enhancement 71" X 62" STD SMS with tape (1)) Suspended top with adhesive 1 08" X 50" STD SMS(1) Suture bag flower (1) Table cover reinforcement 50" X 90"(1) Surgical gown. REINFORCED XLGE TOWEL I WRAP Product Usage: EO disinfection operation convenient package is packed into polyester/polyethylene breathable bag and Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Shoulder Bag (I) (2); Code 900-2515(1) Dress IMP. XTRA REINF. XL towel wrapping class Ill(1) towel absorbent 15" X 20"(1) robe XXL SMS anti-seepage reinforcement(1) MAYO support cover reinforcement(2) tape 24" X 4"(1) sewing bag flower decoration(1) SPLIT W/ADHESIVE 1 08" X 77" STD SMS(1) DRAPE SHOULDER SPLIT W/ADHESIVE(1) Table cover reinforcement 50" X 90" Product use: EO sterilization operation convenient packaging, packaged in polyester/polyethylene breathable Bag with Tyvek double-layer vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-LAMINECTOMY bag-( I) Annular basin LIF (2) Table cover reinforcement 50" X 90" LIF (I) Skin marking ink W/8 label (I) Cautery tip polishing agent LIF (I) Pipe suction connection. W'X 12' LIF (6) Draping utility tape LIF (I 0) gauze sponge 4" X 4" 16PL Y LIF (2) utility bowl 16 ounces. LIF(IO) LAP sponge pre-washed XRD LIF (2) Specimen container 4 ounces with lid and label (2) MAYO bracket cover to strengthen LIF (I) surgical gown. Ryan. XL towel wrap (6) Absorbent towel I5" X 20" LIF (I) Drape knee 102" X 121" X 78" with POUCI-1 SMS LIF(I) Surgical DURAPREP solution 26 ml LIF (6) Drape sheet X 41 "69" medium LIF(2) legging belt 7" cuffs 30" X 42" LIF (2) Needle and blade counter I Oc MAG /transparent (I) cautery pencil push bottom LIF (I) bag stitched flower LIF( I) PVP SCRUB 8" Rod Sponge (I) MAYO Tray Large LIF (I 0) Gauze Sponge 4" X 4" 16PL Y XRD LIF (I) Surgical Blade# I 0 Carbon Steel (2) Bulb Syringe 60cc Transparent Liquid (I ) # II 炭钢(I) Surgical blade# 15 Carbon steel(I) Robe fabric reinforced SONTARA XL LIF(I) Syringe IOcc W/NDL 20G XIY; LILOCK LIF(I) PVP PAINT 8" STICK SPONGE(I) SURGICAL STRIP W'X 6" COTTON (2) LITE GOVES LIFEO sterile surgery convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customized has been confirmed, different catalog numbers (multiple batches) Packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – ANGIODRAPE bag – -(1) Guide wire 0.035" X 150cm(2) Syringe 10cc without needle LUER lock UF(2) Pr. Surgical gloves#8(2) GOWN STANDARD large SMS Velcro 1G 1G W'UF(1) Table cover 44" X 90"(3) Buhak towel blue(2) Utility bowl 16 oz L/F(1) Solution DURAPREP 26ML UF(3) Hanging practical tape UF(3) Towel clip(2) Towel absorbent 15" X 20" UF(1) Needle 18G X 2% AMC/4(1) Femoral vessel cover cloth with bag UF(1) Blanket with bag And tape UF (1) Cup-shaped dentures with lid (30) Gauze sponge 4" X 4" 12PL Y (2) Tip absorbent applicator sponge (1) Scalpel with handle #11 (1) Cock 3 way (1) ) Syringe 30cc without needle LUER lock L/F (1) 30cc needle LUER LOCK L/FEO sterile surgery convenient packaging packaged in a polyester/polyethylene breathable bag with Tyvek double vent Customed Different catalog numbers have been determined The packaging integrity (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Facial Lifting; Code 900-3083; Contains: (I) SHEET ENT SPLIT 110" X 77" LIF(I) COVER TABLE REINFORCED 50" X 90" LIF(I) DRAPE HEAD WITH TAPE 44" X 26" LIF(I) COVER MAYO STAND REINFORCED LIF(I) Bag suture Flower LIF(3) Robe standard large SMS VEL/NELABEL sample(I) Anti-needle and blade 20C foam/MAG LIF(I) STAPLE SKIN 35 Wide Life (I) Tube suction connection W'X 12' L/F( I) Pencil burning rocker switch with holster LIF(10) Gauze sponge 4" X 4" 16PLY XRD LIF(2) Blade# I5 carbon rib (I) needle spine ANEST22G X 3\12 LIF(I) PR. Glove surgery. CUSTOMGUARD neoprene 8.0 POWDER FREE LIF(2) *PR. Glove surgery. 6.5 POWDER LATEX(I) GUT PL FAST ABSORB 5-0(2) SUTURE 2.0 VICRYL 25MM(3) TOWELS ABSORBENT 15" X 20" LIF Product use: EO sterilization operation convenient packaging, packed into polyester/polyethylene breathable bag , With Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-FOLEY Catheter Kit 1116FR. – Customized ED-(1) package 24" X 24" (1) PVP triple cotton swab iodophor (2) GLOVE MED FREETOUCH VYNIL P/F (1) jelly lubrication 5 grams (1) towel 3PLY 17" X 18") SWABSTICK DRY COTTON(1) DRAPE 4" FEENSTRAD 18" X 26" (1) CATHETER 16FR. FOLEY; 2 WAY;5cc; Silicone Coated (1) Syringe 10cc Waterrefil UF (1) BAG URINARY DRAINAGE 20 1) LABEL ID PATIENT (1 ) TRAY ORGANIZER(1) Specimen container 4oz. W/LID & LABELEO sterilization operation convenient packaging, packaged in polyester/polyethylene breathable bag with Tyvek double vents. Customized has determined that the integrity of the package may reduce the different catalog numbers (Multiple batches) will be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-PERY GYN bag-(1) Table cover reinforcement 44" X 78" (1) Drape practical (2) Towel absorbent 15" X 20" (1) GOWN XL SMS IMPERV. Ryan. AAMI LEVEL Ill(1) Drape bottom cloth belt bag 44" X 35" (1) Timeout beacon non-woven fabric (1) Bowl practical blue 16 ounces (1) Bag stitched flowers (1 0) Gauze sponge 4" X 4 "16 XRD (1) Dress IMPERV. EXTRA REINF LGE AAMI LEVEL Ill T/WRAP(1) Conduit 16" 18FR MALE PVC (2) LEGGINS W/7" CUFF 30" X 44"EO sterile operation convenient packaging, packaged in polyester/ with Tyvek double vents The packaging integrity of different catalog numbers (multiple batches) in polyethylene vented bags may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – Laparoscopic Cholecystectomy Surgical Kit – – (1) Drape Laparoscopy/Abdominal UF (1) Gown IMPER. Extra reinforced LGE TIVVRAP(1) Scalpel #11 stainless steel (1) Time-out beacon non-woven fabric UF(10) Gauze sponge 4" X 4" 16PLY XRD UF (1) Robe XLARGE SMS IMPERV. Enhanced (3) Towel absorbent 15" X 20" UF (1) Pipe inflation kit without ring (1) MAYO support cover enhanced UF (1) Needle and blade counter 20c Foam/MAG UF(1) RCED 90 "Table cover reinforcement" UF (1) Skin marking ink/8LABEUTIME OUT/RULER(1) Hanging sheet 41" X 58" SMS UF (1) Bag stitching flowers (4) Hanging practical UF (1) TUR CYSTO IRRIGATION SET 79" Single UF(1)) TUBE SUCTION CONNECT. 3/16" x 12' UFEO Sterilized Surgery Convenience Bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Angiography Package-(1) Femoral Angiography. Cloth sheet with bag(2) Syringe 10cc with 0 needle LUER lock LIF(2) Needle injection 21G X 1%(1) Reinforced table cover 44" X 78" LIF(30) Gauze sponge 4" X 4" 1P The robe is impermeable and reinforced large SMS(1) The robe is large non-reinforced SMS Towel and wrap(1) Guide wire 0.035" X 150 cm removable(2) Bag blanket and tape L/F(2) Denture cup( 81 oz) 3cc needle-free LUER lock LIF(1) needle injection 18G X 1%( 1) 30cc needle-free LUER lock L/F(4) with tape L/F(2) solution surgical ml LURAREP(26) Towel clip(1) Needle 18G X 2% AMC/4(4) Towel Bukhak blue(1) Practical bowl 16 oz LIF(1) Scalpel with handle# 11EO Sterile operation convenient bag, using Tyvek polyester/ Polyethylene double-layer air-permeable bag packaging vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients or loss of sterility due to product contamination.

Customized on August 29, 2014; Inc Customed – Tummy Tuck Pack-BOD; Code 900-3026; Contains: (2) GOWN X-Large SMS IMPERVIOUS REINFORCED AAMIIII(2) Towel absorbent 15 X 20(1) Pencil burning push Bottom (1) Anti-needle/blade 20C foam/MAG(1) Bowl 32 ounces utility cover MAYO bracket enhanced (2) Skin marking ink with 8 labels/timeout/ruler (1) Enhanced cover sheet 50 X 90 (1) Cup denture 8 ounces cyan with lid (1) Ruler ACCU-6(6) Towel CLOTH HUCK C BLUE(1) TUBE SUCTION CONNECT (1) DRAPE BREAST/CHEST(2) LITE GLOVE Product use: EO sterilization surgery Convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Fan-shaped Folding-Customized (1) Folding sheet 42" X 57" SMS(1) WRAPPER 24" X 24" EO sterile surgical convenient packaging, packaged with Tyvek double vents In a polyester/polyethylene breathable bag. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – ARTHROSCOPY PACK – (1) MAYO support cover reinforcement LIF(1 0) Gauze sponge 4" X 4" 16PL Y(1) TUBE SUCTION CONNECTING X" X 12' LIF(1) IMP. STOCKINETTE(1) Surgical blade #11 stainless steel(1) Anesthesia spinal needle 18G X 3 ~(1) Syringe section with needle 21G X 1 ~ Luer lock LIF(2) Elastic bandage 6" X 5 yards LIF(1 ) TUR Y set 1AMREGAR2" (2) Needle subcutaneous injection 18G X 1 ~(1) Table cover 50" X 90" reinforced LIF(5) Towel absorbent 15" X 20" LIF(2) Drape with tape LIF Utility (1) DURAPREP surgical fluid 2 I LIF 1) U-DRAPE 60" X 70" with tape bifurcation (1) Pr. Neutral surgeon gloves #7.5(1) Pr. Neutral surgeon gloves #8( 1) Pr. Neutral Surgeon Gloves #8.5(2) Replacement Gloves-Large SMS(10) Gauze Sponge 4" X 4" 16PLY XRD(2) Strip(1) Sheet Arthroscopy T STD SMS Bag LIF( 1) Pendant video camera LIFEO sterile surgery convenient packaging, packaged in a polyester/polyethylene breathable bag Tyvek double vents. Customization has been determined to have t Packaging integrity may be damaged due to different catalog numbers (multiple batches) This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Caesarean section package-(3) Absorbent towel 15" x 20" LIF(1) 80 oz plastic bowl with lid. (1 0) Knee sponge pre-wash 18" x 18" XRD(2) Pad obstetrics X Big ST.(1) MAYO support cover reinforced LIF(1) Overhang piece 41" x 58" SMS LIF(2) Pipe suction connection . Y.." X 12' LIF(1) Ear Ulcer Syringe 2 oz. LIF(1) YANKAUER Suction Tube without Vent L/F(1) Umbilical Cord Clip(1) Surgical Blade #20 Carbon Steel(1) Table cover reinforcement 50" X 90" LIF(1) IMPERVIOUS REINFORMED X-Large SMS LIF(1) DRESSING ISLAND 4" X 1 0"(1) C-Section Drap with Pouch 102" X 121" X 78"(1 ) Printed baby blanket (1) GOWN IMPERVIOUS REINFORCED LARGE SMS(1) BAG SUTURE FLORALEO Sterilization operation convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-curtain cloth; product code 2942; contains(1) DRAPE% ECONOMY 53 X 77L/F(1) WRAPPER 24 X 24 L/F Product use: EO disinfection surgery convenient bag, packaging Polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – BASIC PACK IV (6) CUSTOMEDCONTENTS: (3) TOWELS ABSORBENT 15"" X 20""(1) MAYO STAN COVER REINFORCED (1) DRAPE% ECONOMY 53"" X 77 ""(1) DRAPE SHEET 41 ""X 58"" SMS(4) Practical drape belt (1) Sewing bag flower (1) Reinforced table cover 44"" X 78""(2) GOWN SOFT SMS STD; XLGE SET IN SLEEVE product use: EO sterile packaged in a polyester/polyethylene breathable bag with Tyvek double vents. "Customed has determined that the package integrity of different catalog numbers (multiple batches) may be affected. affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – ARHTROSCOPY PACK- (1) U-DRAPE 60" X 70" WITH TAPE SPLIT(1) GOWN IMPERVIOUS EXTRA REINFORCED X-Large(1) TOWEL ABSORBENT 15" X 20"(1 ) MAYO Stand Cover Reinforced(1) Table cover reinforcement 50" X 90"(1) Pouch stitch flower(1) STOCKINNETTE IMPERVIOUS 14" X 48"(4) Strip 24" X 4"(1) Sheet end ABS . 125" X 85"(1) TIME OUT BEACON Non-woven ST.EO Sterilization Surgery Convenience Bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-LAP Abdom w/pouch custom code 900-2619; includes: (1) DRAPE LAP. ABDOM W/POUCH 102" X 122" X 78"(1) WRAPPER 30" X 30" Product use: EO sterilization surgery convenient bag is packed into polyester/polyethylene breathable bag with Tyvek double vents. The customer has confirmed It is possible that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Laparotomy Package-Contents: (1) GOWN XL SMS IMPERVIOUS reinforced LIF (1) MAYO stent cover reinforced LIF (1) bag suture flower LIF (4) drape with tape LIF Utility (2) Overhang II X58 SMS L/F(1) Table cover 50" X 90" LIF(1) Solution DURAPREP 26ML LIF(1) Blade surgery # 10 Carbon steel (5) Knee sponge prewash 18" X 18' XRD LIF(6) Towel 15" X 20" LIF(1) CAUTERY TIP POLISHER L/F(2) Utility bowl 16oz LIF(1) TUBE SUCTION CONNECT%" X 12' LIF(2) Needle and blade counter 10c MAG /CLEAR LIF(1) Curtain T LAPAROTOMY 102" X 78" 121" SMS STD LIF(1) Specimen container 4 oz, with lid and label (1) YANKAUER suction tube, without exhaust LIF(1) Time-out letter Standard non-woven fabric LIF(1) protective clothing REINFORCED XLGE TOWEL & WRAP LIFEO sterile surgical convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customized has been confirmed, different catalog numbers (multiple Batch) packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – LAPAROSCOPY ABO PACK (1) (2)CUSTOMEDCONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15"" X 20""(2) ) GOWN X-Large SMSIN IMPERFIOUS RE (1) MAYO STAND COVER REINFORCED (4) Draping utility with tape (1) Suture bag flower (1) Draping laparoscope tube W/TROU (1) Table cover reinforcement 50"" X 90 "" Product use: EO sterile surgical convenience package is packaged in a polyester/polyethylene vented bag with Tyvek double vents." Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected . This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – TRANSVERSE LAPAROTOMY PACK (8)CUSTOMEDCONTENT: (1) TOWEL ABSORBENT 15"" X 20""(1) MAYO STAND COVER REINFORCED (4) DRAPE Utility WITHffAPE(1) Stitched bag Flowers (1) TRANSLAP LAP 1) Table cover reinforcement 50"" X 90"" (1) GOWN SURG. REINFORCED XLGE TOWEL & WRAP (1) GOWN XL SMS IMPERVIOUS REINFORCED Ethylene vented bag with Tyvek double vents. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customized-Angiography Package Content: (4) Buhak towel blue (1) Table cover reinforced 50"" x 90"" LIF (2) Syringe 20cc needle-free Luer Lock L/F (2) Cup of medicine 2oz LIF practical bowl 32oz LIF(1) EMESIS basin 101N 700cc(4) Towel clip(3) Towel absorbent 15"" x 20"" LIF(1) Mosquito HALSTED(2) Permethrin SWABSTICK 5.1ML platform(1) Platform(1) SCALPEL SAFETY #11(3) Skin marking label(1) Label F/MED. Normal saline blue(1) Injection needle 18G X 1 Y2(2) Syringe 10cc without needle LUER lock LIF (1) WL utility (16oz) drawstring bag with blanket and tape LIF (20) gauze sponge 4"" X 4"" 16-layer XRD LIF (1) Femoral Angiography Band Bag (1) Needle 21G X 1 Y2 (1) GOWN STANDARD2 SMS LARED HYPODERMIC 23GA X 1""(1) Robe SMS Large non-reinforced towel/wrap (1) Drug label Violet (1) Drug Mocaine label yellow (1) Green label of drug contrast agent (1) ROUND6 BASHQ use: EO sterilization operation facilitates the aging of the bag into a polyester/polyethylene breathable bag with Tyvek double vents. "Customed has been determined, the package integrity may vary The catalog number (multiple batches) is affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-0.B. Packaging-HSCH- (1) PVP frosted 8" stick sponge (1) Hip drape with pouch (2) Leg 30" X 42 with 7" cuffs "(1) Abdomen drape tape LIF(1) Sponge knee prewash 18" X 18 inches XRD LIF(1) Bowl plastic with lid 80 oz LIF(1) Receiving blanket 100% cotton(1) Baby blanket impermeable poly ABS .LIF(1) Umbilical cord clamp(3) Absorbent towel 15" X 20" LIF(1) Utility bowl 16 oz LIF(2) Tray organizer full depth(3) Suction head applicator(2) Glove check medium(1) ) G large towel/wrap(10) gauze sponge 4" X 4" 12PLY(2) pad obstetric X large ST. LIF(1) ear ulcer syringe 2 ounces UF(1) baby cap(2) sheet 41 inches X 58 Inch SMS(1) Scissors umbilical cord(1) Reinforced table cover 44 inches X 78 inches L/F(2) Wrapping paper 24 inches X 24" LIEO sterile surgical convenient packaging packaged in polyester/polyester with Tyvek double vents Customed in ethylene vented bags has been determined, and the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Laparotomy Kit-(I) Surgery Blade #10 S/Steel (I) Practical Bowl 32oz(I) Practical Bowl 16oz (2) Needle and Blade Counter IOC MAG/CLEAR(I ) Surgical drape T LAPAROTOMY STD SMS (2) Absorbent towel 15" x 20" (2) Robe IMP. Reinforced large SMS (4) Draping utility with tape (I) Reinforced table cover 50" X 90" (I) MAYO support cover reinforced (I) Electrode double pressure/grounding pad (I) Cautery pen rocker switch 422 The "X 55" SMSEO sterile surgical convenient packaging is packaged in a polyester/polyethylene vented bag with Tyvek dual vents. It has been determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc" Customized-Shoulder Packaging Code 900-2766 Content: (1) STAPLE SKIN 35 WIDE LIF(1) *GOBAN SELF-ADH 4"" X 5YD WRAP TAN LATEX (2) U- DRAPE 60"" X 70"" WITAPE SPLIT "" X 21""(1) Table cover 44"" X 90""(4) Towel absorbent 15"" X 20"" LIF(2) Pipe suction connection"" X 12' LIF(1) Skin Marking Ink W /8 Label/Timeout/Scale Life(1) Bag Suture Flower(1) Syringe 20cc with 0 Needle Luer/Lock Life(1) Scalpel Weighted Safety #11(1 ) Needle spinal anesthesia 18G X 3% life (1) DRAPE INCISE antibacterial 23"" X 17"" LIF (1) CHLORAPREP 26ML APLICATOR TEAL LIF(2) Removable bag beach chair 35"" X 43"" with suction Part (4) DRAPE Utility WITAPE L/-( DRAPE small towel DRAPE NPN-STERILE 17"" X 11"" LIF (1) BOWL UTILITY 32oz. (1) STOCKINETTE 6"" X 48"" L/F(5) LAP SPONGE PREWASH 18"" X 18"" XRD LIF (1) Wrap 24"" X 24""(1) Needle 22G X 1 %(1) GOWN SURG Reinforced Oversized Towel I Wrap (1) Robe MICROCOOL IMPERV. Extra long X large ORPEDICRA split (1) Meosta ND COVER REINFORCED LIF Product use: EO sterilization surgery convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents.” Customed has been confirmed , The packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Laparoscopic Cholecystectomy Package-(1 0) Gauze Sponge 4" X 4" 16-layer XRD UF(2) Absorbent Towel 15" X 20" UF(1) MAYO Bracket Cover Reinforced UF(4) Bandage x3 "LIF(4) DRAPE Utility WIT APE UF(1) TUBE SUCTION CONNECT. Y.." X 12' UF(1) INSUFLAT TUBING SET W/0 RING ADAPTER UF(1) LAPAROSCOPY ABO. DRAPE W/Pouch UF(1)) IMP. GOWN REINFORCED XLge. SMS(2) Syringe 60ML W/0 NDL.LILOCK UF(1) SYRNGE 20 cc W/0 NDL ULOCK UF(1) Surgical blade #15 C/steel (1) Scalpel with laser camera W/ EL(2) COVER HANDLE LITE LOCK(1) Reinforced table cover 50" x 90" UF(3) Overhang piece 41" x 58" SMS(1) SURG. GOWN REINFORCED T /Wrap Lge.EO Aseptic surgery convenient packaging polyester/polyethylene breathing bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-OB bag-(I) Table cover reinforcement 50" X 90" LIF(I) Hip drop belt pocket 44" X 35"(2) Legging belt 7" Cuff 30" X 42"(1) Dress Large SMS IMPERVIOUS Enhanced(3) Towel Absorbent 15" X 20" LIF(I) Pad Obstetrics X-Large ST.(I) PACKING VAG JNAL 4" X 36" 8PL Y XRD( 10) Gauze sponge 4" X 4" XRD(12PLY) I) Umbilical cord clip(1) Baby blanket printing(2) Ear/ulcer syringe 2 ounces. LIF(I) Protective sleeve 42" X 75" CLEARPOLY(1) Abdomen hanging 80 oz. plastic with L/F(1) bowl and lid. L/F(1) SHEET DRAPE 41" X 58" SMS LIFEO Sterile Surgical Convenience Bag, packaged in polyester/polyethylene breathable with Tyvek double vents In the bag. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – LAPAROSCOPY PREMIUM PACK – (1) Table cover enhanced version 50" x 90" UF(4) Towel absorbent 15" x 20" UF(10) Gauze sponge 4" X 4" 16PLY XRD UF(1) Pleated Camera Laser/EL UF(1) TROCAR Endo.XCEL Expansion Tip (KSLT)(1) Application Clip 5mm(3) Robe XLGE SMS IMPERV. Reinforce (1) Blade Surgery #11 S/Steel (1) Needle-type inflatable air cushion. The 150 mm UL UF(1) MAYO stent cover strengthens the UF(1) drape over the laparoscopic abdomen. W/POUCH(4) DRAPE Utility with TAPE UF(1) Tube inflation kit W/0 Ring adapter U/F(1) TROCAR expansion XCEL 5MM x 100 (D5LT)(1) TROCAR Endo.XCEL expansion tip 11MM(1) SUTURE BAG FLORAL UF(1) ClosURE SKIN W'X 4" STERI STRIP LFEO Sterile operation convenient packaging, packaged in polyester/polyethylene breathable bag with Tyvek double vents. Customed has confirmed the packaging integrity in different catalogs The number that may be affected (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-PERl GYN PACK-(1) Towels are not ABS. With L-shaped tape/free (1) hip drape belt pouch (2) towel absorbent L/free (2) tights with 7-inch cuffs (1) draped top WI adhesive (1) tablecloth reinforcement. L/Free(10)) GAUZE SPONGE 4" X 4" 16PLY XRD LIF(1) Catheter 14FR ROBIN NELAT PVC(2) GOWN LGE SMS IMPERVIOUS REINF.EO Sterile operation convenient packaging, packed in a Tyvek double vent In a polyester/polyethylene breathable bag. Customed has determined that packaging integrity may be compromised due to different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – CERVICAL PACKADVANCED AMBULATORY SURGICAL CENTERCONTENTS: (1) Cover Table Reinforced 50"" X 90"" (1) COVER FLUORO 30"" X 30"" Rubber Band (8) Towel Bukhakhi blue (1) S Y. 60"" X 77"" drape enhancement (10) gauze sponge 4"" X 4"" 16PLY XRD (1) skin marker tape ruler (1) drape thyroid 100"" X 142"" X 72"" (1) TAPE TEGDERM 2-3/8 X 2-3/4(1) SOLUTION SURGICAL DURAPREP 6ML (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VI (1) pin 30G X 1 DISP (2) Gauze sponge "X 2"" 4PLY non-woven fabric (1) Strip STERI closed %" X 4"" (2) Tunic soft SMS STD XL set (4) Needle 18G X 1% (1) Ruler flexible Plastic (4) 3CC needle-free LUER lock (1) Bag zipper lock (1) Strip STERI DRAPE LARGE 17"" X 23"" (9) Skin marking label Product use: EO sterilization operation convenient packaging packaging into polyester/poly Vinyl breathable bag with Tyvek dual vents.” Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc" Customized-Laparoscopy package content: (I) bulb syringe 60cc LIF (I 0) gauze sponge 4"" X 4"" 1 6PLY XRD LIF(I) MAYO STAND COYER REINFORCED LIF (I) Watch cover 590"X" ""LIF(3) GOWN SURG. Enhanced XL super long class IV (4) Towel absorbent I 5"" X 20"" LIF(I) Overhanging video camera I 3cm X 244cm LIF (3) LITE G LOVE LIF(I) DRAPE LAP ABDOM. WI POUCH 102"" X 122"" X 78"" (I) BLADE SURG ICA L # II Stainless steel (I) syringe I Occ, needleless LUER lock LIF (4) Draping utility with tape I) Suture bag flower (I) Needle and blade counter I OC MAG IC LEAR L/1' (I) Cable lap. IOFR 4MM MALE MONOP. LIF (2) Dressing is not ADH TELfoA 4 X 3(I) Specimen container 4oz lid and label (2) SH EET'll.o 60"" X 77"" DRAPE REI NFORCED LIF(I) Tube inflation device with ring adapter LIF (I) CI-I LORAPREP 26ML Applicator Cyan LIF(I) 24 Package "" X 24""(2) Denture Cup 8 oz WILIDADHERED Outer package into a bag: (I) NEE DLE ULTRA VERES 1 20MM LIF( I) TROCAR Endo.XCEL DILATING TIP IIM M (D IILT)( I) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT)( I) CANNU LA 5MM XCEL SLEEVES LIF Product use: EO surgery is conveniently packaged in a polyester/polyethylene breathable bag with Tyvek double vents "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Hair Repair Kit-; Code 900-2966; Contains: (1) MAYO bracket cover 23X54 (2) Terry cloth HUCK blue (2) Table cover rear area reinforcement 44 X 90( 2) The robe is soft SMS STD. X-Large AAMI Ill(2) Towel Absorbent 15 X 20(1) Knife 1.0 mm; wide; 40 degree angle; 6.0 mm long Product use: EO sterilization surgery convenient bag, packaged with Tyvek double vent In a polyester/polyethylene breathable bag. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-breast implant package; code 900-2660; contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE set (3) towel absorbent 15 X 20 (1) MAYO Reinforced Stand Cover (2) Reinforced Table Cover 50 X 90 (1) BAG Flower (1) Tube Suction Connection Y (6) Terry Cloth HUCK Blue (4) Abdomen Pad 8 X 7.5 (2) LITE Gloves(1) Cautery tip polisher LIF(1) Blade surgical carbon steel 15(1) TUERKTION YAN /0 VENT(1 0) LAP SPONGE PREWASH 18 X 18 XRD(1) CAUTERY PENCIL ROCKER SWITCH W/HOLSTER(1) UNDERPAD 23 X 36 Product Usage: EO sterilization operation convenient bag is packed into polyester/polyethylene breathable bag and Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customized-Liposuction package aesthetic surgery. Central content: (1) Blade surgery. #11 carbon steel (3) * GLOVE PERRY SURG. #7LATEX (15) Sponge pad pre-wash 18" "X 18"" XRD L/F (4)) * GLOVE PERRY SURG. # 7 Latex (1) Table cover REINF 50"" X 90"" LIF (2) Robe SOFT SMS STD XL Set on sleeve L/F ( 4) Curtain fabric 44"" X 58"" SMS LIF (1) TRAY ORGANIZER FULL DEEP(3) SHEET% 53"" X 77"" REINF. LIF (2) TOWELS ABSORBENT 15"" X 20"" LIF : EO sterilization surgical convenience package, packaged in a polyester/polyethylene breathable bag with Tyvek double vents.” Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "customized-vaginal surgical kit customization EDCONTENTS: (1) drape lithotripsy 110"" X 63"" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF(1) REINFORCED LIF(1) REMOVIN MAYO STAND (1) Bag suture flower(1) Cover table REINF 50"" X 90"" LIF(1) Pipe suction connection. W'X 12' LIF (1) GOWN SURG REINF XL T/WRAP(20) Gauze sponge 4" "X 4"" 16-layer XRD LIF (1) Pencil sharpener manual switch (1) PVP coating 8"" stick sponge (1) PVP scrubbing 8"" stick sponge (1) Syringe 20cc W/0 NDL Luer lock LIF (1)) Towel absorbent 15"" X 20"" LIF(1) YANKAUER suction tube W/0 VENT LIF (1) Pre-pad with cuffs (1) ) Packaging vagina XRD 4"" X 36"" 8PLY (2) Pad obstetric XL (1) Catheter 2/W 16Fr. PRESS W/UBAG 2000ML (1) TIME OUT BEACON Non-woven LIF Product Usage: EO sterilization and convenient operation Packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents.” Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc" Customized-Femur Pack Content: (2) Towel absorbent 15"" X 20"" LIF (2) Overhanging sheet 42"" X 57"" SMS LIF(1) SAFETY IV INTROCAN 18 X 1X ST. LIF(2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF (2) Vascular ring surgery MAXI BLUE(1) Suture assisted guidance STD Yellow ST. LIF(1) YANKAUER suction tube, no exhaust L/F(1) EMESIS BASIN 101N LIFELSHIL(7200D) 1) Needle injection 18G X 1 L/F (1) Catheter IV safety 20G X 1X LIF(1) DRAPE T LAPAROT 102"" X 78"" X 121"" SMS STD LIF (10 ) Knee sponge prewash 18" X 18"" XRD LIF(1) MAYO support cover reinforced LIF (1) STOCKINETTE IMPERVIOUS 14"" X 48"" LIF(2) Syringe 20cc needleless LUER I lock life (1) suture Bag flower LIF(2) 16 WLUTILITY. L/F(1) CAUTERY TIP POLISHER LIF(1) Reinforced workbench cover 50"" X 90"" LIF (4) Draping utility and tape LIF(1) MAYO TRAY SMALL( 1) SCALPEL SAFETY WEIGHTED #15 (1) Scalpel safety weighting #11 (2) Pipe suction connector X"" x 12' LIF (2) Needle and blade counter; 1Oc MAG/CLEAR LIF (1) Time OU T Beacon None Woven fabric LIF(1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER L/F Product use: EO sterilization operation convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. "The customer has determined that there is a possibility that the integrity of the package may be compromised due to different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Extreme Pack; Code 900-2615; Contains: (5) Knee sponge prewash 18" X 18" XRD(1) Elastic bandage with Velcro 4 X 5(2) Blade Surgical #15 Stainless Steel (4) Draping Utility with Tape (1) GOWN XL SMS IMPERVIOUS (REV)) GOWN SURG Reinforced Large Towel and Wrap (1) Skin Marker with Ruler (1) Pipe suction connection Y4 "X 12'(1) CAST PADDING SOFT ROLL 4" X 4yds(10) Gauze sponge 4" X 4") MERLING SKIN PREP APPLIC 39ML(1) MAYO reinforced bracket cover (1) reinforced table cover 50" X 90 "(2) Overhanging piece 42" X 55"(1) STOCKINETTE 9" x 48"(1) NCIL CAUTERY ROCKERY SWITCH (2) LITE GLOVE(1) BANDAGE ESMARK 6" X 9yds(1) SHEET EXTREMITY ABS SMS 125" X 85"(1) UTILITY BOWL QUART 32oz Product use: EO sterilization surgery convenient packaging, packaged in a polyester/polyethylene vented bag with Tyvek double-layer vented bag vents. Customized has been determined, different catalog numbers (multiple Batch) packaging integrity may be affected. This may cause harm to patients due to product quality issues, amination or loss of sterility.

Customized on August 29, 2014; Inc "customized-ear bag content: (I) CAUTERY PENC IL ROCKER SW I TI-I CH (I) EMESIS BASIN l Oin 700cc (2) Skin marking label (I) Needle HYPODERMIC 1 80 XIY; (I) WASI- l BASIN ROUND 6QT(I) Instrument bag 7 XII 2 COMPART(I) STRIP STER I closed W'X 4"" LIF(I) Syringe 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/ 0 needle LILOCK LIF (I) cauterization polishing machine TI P LIF( I) SH EET ENT SPLIT 11 0 X 77(2) LITE GLOVE(2) needle HYPODERM IC 27G XI \!.."( 1 2) Towel cloth bag (blue) (I) pipe suction connection. '!."" X 12' L/F (I) Ear Ulcer Syringe 2oz LIF(I) Table COYER Reinforced 50"" X 90"" LIF (I) Practical Bowl 1 6oz LIF (4) COTRON Applicator 6" "WOOD(I) Instrument Wiper I MM 8.25 X 8.25(I) MAYO Holder COYER Enhanced LIF(I) Needle and Blade Counter 20c Foam/MAG LIF (I) W/Skin Mark I) Syringe IOcc W/0 NEEDLE LILOCK LIF (I) Tray MAYO SMALL(I) Syringe E IOcc TI P Control LILOCK LIF(I) Pendant microscope ZEI SS(I) Towel absorption ENT 1 5" X 20"" LIF(I) Time-out beacon non-woven EN ST LIF(I) blade micro carbon steel (I 0) gauze sponge 4"" X 4"" 1 6PLY XRD LIF(I) needle blunt filling 1 80 XIY; (2) scalpel safety weight # 1 5(I) surgical gown ; I MP ER. MI CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL(I) MERLINO skin preparation application. 39 ml LIF(I) package 24"" X 24"" wet skin package contains: (I) package 30" "X 30""(I) Tray 3/COMPARTM ENT(I) PYP SCRUB SOLUTI ON 4oz. BOTrLE(3) TI P Water Absorbent Spreader Sponge(3) Towel Absorb 15"" X 20"" L/F (6) Sponge Wing Little Life (2) Gloves MED FREETOUCI-1 VYN ILP/F(2) COTRON Applicator 6 "" WOOD Product use: EO sterilization operation convenient packaging, packaged in polyester/polyethylene breathable with Tyvek double vents In the bag.” The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-PHACO Packaging-(10) Gauze sponge 4" X 4" 12PLY (2) Syringe 3cc W/NDL. 21 grams X 1%" (2) medicine cup 2 ounces. (1) Eye mask with bag (1) Long gown standard LGE.SMS (1) Long gown non-REINF. Lge. T/Wrap SMS (1) Universal eye mask (1)) Table cover 44" X 90"(1) MAYO stand cover REINF.LIF (3) Absorbent towel 15" x 20 LIF(2) Eye pad 2 1/8 X 2 5/8 LIF (1 0) EYE SPEAR micro sponge VELCRO /NECKEO Sterilization Surgery Convenience Bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-breast augmentation package; Imagenes cosmetics; code 900-2682: (3) Sleeve soft SMS STD XLGE set (1) Cautery pen push bottom (1) Tube suction connection (1) MAYO bracket Cover reinforcement (1) Skin marking ink W Cover (2) 50 X 90 (1) Ruler 6 Transparent (6) Terry cloth bag (blue) (10) Knee sponge pre-wash 18 X 18 XRD (1) Burning head Polishing machine (1) YANKAUER straw with / O VENT( 1 / BRAPEPE) CHEST SMS Product use: EO sterilization surgical convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Laparoscopy Package--(1) Abdominal drape belt with bag (1) CAMRA drape 9" X 96" LIF(5) Towel absorbent 15" X 20"(1) ) MAYO Support Cover Reinforcement (1) Table Cover Reinforcement "X 90" (4) Hanging and practical, with tape (3) Hanging piece 41" X 58" SMS(1) Tracheal inflation device with 0 loop adapter (5) Knee Sponge prewash 18" X 18" XRD(1) GOWN LGE SMS IMPERVIOUS enhanced(2) robe X big SMS IMPERV. Fortified (2) medicine cup 2 ounces. (1) Needle 18G X 1% ST. (1) Blade surgery. # 15 Carbon steel (1) Syringe 10cc without needle Luer lock (2) Needle and blade counter 1 Oc MAG/CLEAR(1) Dressing TEGADERM 4" X 4%" (1) Solution DURAPREP TRAY 6mL (1) SM 1) Pipe suction connection. %"X 12'(10) GAUZE SPONGE 4" X 4" 16PLY XRD(1) NEEDLE ECLIPSE 22 X 1%(1) TIME OUT BEACON NON WOVEN STEO Convenient packaging for sterilization surgery, packaged in a poly with Tyvek double vents Customed in the ester/polyethylene breathing bag has been determined, and the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – LAPAROSCOPIA COLORECTAL PACKCONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml(4) DRAPE Utility with TAPE(1) TOWELS ABSORBENT 15"" X 20"" (2) LEGGINS W/7" "Cuffs 320"" "(1) Scalpel #15 stainless steel (1) Scalpel #11 stainless steel (1) Robe IMPERV. Extra reinforced XLG (1) Robe LGE Standard SMS Velcro (1) Flush suction port (TROMPET) Double connector 4"" X 4"" 16PLY XRD(2) Utility bowl 16oz(2) STERI strip closure W'X 4""(1) ACTIFOG W/foam cushion solution (1) Table cover reinforcement 50"" X 90"" (1) MAYO support cover reinforcement (1) ULTRA VERES 120MM (1) STAPLE hinged trapezoid 60MM (1) re Install the white 60MM ECHELON (1) Reinstall the blue 60MM ECHELON (2) Sleeve 5MM (with STELEV SLEE) SLEVE (1) TROCAR 12 mm blade with anti-stab sleeve (1) overhanging the knee. ABDO tape bag 102"" X 122"" X 78"" STD SMSProd uct Purpose: EO sterilization surgical convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-customized femoral pack; convenience pack includes multiple components: syringe 3cc; 5cc; 10cc; 20cc; swab ammonium chloride; needle; gauze/sponge; tablecloth; absorbent towel; stop mosquitoes Cardiovascular disease; gown; bowl; wrapping paper; scalpel safety; mosquito forceps; Buhak; clip towel; fluorine covering; medicine cup; femoral vascular drape; mayonnaise tray; counter and label. Convenient packaging for EO sterilization surgery, packaged in a polyester/polyethylene breathable bag with Tyvek double vents, Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – Caesarean section package (4) Customized content: (4) Towel absorbent 15" X 20" (2) Enlarged robe with SMS impermeable reinforcement (1) Cover MAYO bracket reinforcement (2) Curtain fabric 41" X45) Draping utility with tape (1) Bag stitching flower (1) Drape T Laparotomy 102" X 78" X 121" STD SMS (1) Table cover reinforcement 50" X 90" Product use: EO Convenient packaging for sterilization surgery, packaged in polyester/polyethylene breathing bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Arthroscopy Bag- (2) Absorbent towel 15" x 20" LIF(1) TUBE SUCTION CONNECT Y.." X 12' LIF(1) Elastic bandage 6" X 5yrd. UF(1) IMPERVIOUS STOCKINETTE 14" X 48"(1) HUCK cloth towel white (1) MAYO support cover reinforcement LIF(1) U overhang 60" X70" with slits (4) strip 24" X 4" L/ F(1) STOCKINETTE 6" X 48" LIF(1) MAYO Tray Small(5) Hackcloth Towel Blue(2) Practical Bowl 32 oz(2) Dress Surgery Strengthening X Major IV(1) Solution Surgery 26 Milliliters of cemented carbide 1) ABS at the end of the sheet. 125" x 85" SMS(5) LAP sponge pre-wash XRD(1) YANKAUER straw without vent (1) Pencil burning rocker switch (1) Skin marking ink with 8 labels (2) LITES gloves UF And (2) Blade Counter 10C MAG/CLEAR(1) CAUTERY TIP POLISHER UF(4) With tape UF(1) BAG BIHAAZARD 30" X 37"(1) BAG SUTURE FLORAL(1) Table cover BTC 77" X 110" HD full cover UF(1) GOWN IMPERVIOUS EXTRA REINFORCED X-Large TOWEL/WRAPEO sterile operation convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – LAPAROTOMY PACK 1 (2&3) CUSTOMEDCONTENT: (2) TOWEL ABSORBENT 15"" X 20""(1) MAYO STAND COVER REINFORCED (4) DRAPE Utility WITHffAPE(1) SUTURE BAG FLORAL(1) DRAPE TLA2 ""X 78"" X 121"" STD SMS (1) Table cover reinforcement 50"" X 90"" Product use: EO sterilization surgery convenient bag, packaged in a Tyvek double vent Polyester/polyethylene breathable bags. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customized-LAPAROTOMY PACK BASICCODE 900-2829 Content: (2) Towel absorbent 15"" X 20"" (1) Cover MAYO bracket reinforcement (4) Draping utility with tape ( 1) Bag stitched flowers (1) Drape pleats 10 ""X 78"" X 121"" STD SMS(1) Reinforced cover sheet 50"" X 90""(1) Robe XL SMS Impermeable reinforced AAMI LEVEL Ill(1) Time-out beacon non-woven fabric(1) Counter NDUBLADE 20C FOAM/MAG(1) SKIN MARKER INK W/8 LABEUTIME OUT/RULER(1) Extra-reinforced large towel and wrapper for impermeable robe AAMI LEVEL Ill Product use : EO sterilization surgery convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents.” Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Cholecystectomy All Endo System; Code 900-3025; Includes: (1) Table cover 44X 90 UF (1) Syringe 20ccW/O NDL LUER LOCK LIF (2) MAYO bracket cover Strengthen UF (1) Needle injection (6) Absorbent towel 15 X 20 UF (1) Injection needle 21 years. UF(4) UTILITY DRAPE WIT APE UF (1) TROCAR Expansion XCELL 5MM X 100(3) GOWN XL SURGICAL MICROCOOL L/F (1) TROCAR Endopath XCEL Expansion Tip (1) Wrap 24" X 24" TUBING UF (1) Insufflating OPEN TIP W/0 VENT UF(1) DRAPE LAP ABDO. With bag 102 X 122 X 78 STD UF (5) Applicator cotton 6 wood UF (1) ULTRA VERES needle 120 mm LIF (1) Applicator multi-clip gun with handle (1) Specimen container 4 oz. With cover and label UF (2) Overhang: Y. Economical 53" X 77" UF(2) practical bowl 16 oz. UF (1) SCALPEL weighted safety #11 UF(1) Ring basin (1) Timeout beacon non-woven fabric UF(1) Pipe suction connection (1) MERLING SKIN PREP APPLIC 39ML UF(1 0) Gauze sponge 4 6 XY 4 XRD LIF (2) Towel Buhak (blue) UF (1 0) Gauze sponge 4 X 4 16PL Y UF (1) Scissors bending belt monopolar cautery 5 mm (5) Knee sponge prewash 18" X 18" XRD UF (1) Curved dissector with MONOPLAR cautery device 5 mm (1) Skin marking ink with 8 LABEUTIMEOUT/RULER LIF (2) Lens hood UF (1) Suture bag flower UF (4) Dressing island 4 X 6 (1) Crinkle camera/flexible 6X 96 (1) PK. STERI STRIP CLOSURE (1) Number of needles and blades 60C FOAM STR/MAG STR UF (1) MAYO TRAY SMALL(1) SYRINGE 30ML SLIP TIP 1 ML UF Breathable bag vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Caesarean section package-(1) Table cover reinforcement 50" X 90" L/F(3) Towel absorbent 15" X 20" L/F(1) Baby blanket (1 0 ) Gauze sponge 4" X 4 "16-layer XRD LIF(1) surgical gown. SMS POLY-REINF Breathable IMPERV XL T/WRAP LEVEL IV(2) Mat Obstetric XL LIF(1) LITE GLOVE LIF(1) Overhanging piece 41" X 69" Medium LIF(2) Surgical blade #10 Carbon steel(1) 20cc without needle LUER lock LIF(1) bag glass (2) needle and blade counter 1 OC MAG/CLEAR(1) 64oz container with lid (1) syringe 1 Occ without needle LUER lock FOUF(1) MAYORCED COVER 1) Bag suture flower(15) Knee sponge pre-wash XRD LIF(1) Ear ulcer syringe 2oz UF(1) Umbilical cord clamp L/F(1) Washbasin? QT.(1) Cautery tip polisher LIF(1) ) YANKAUER suction tube with 0 exhaust LIF(1) Laparotomy belt with bag 102" X 121" X 78"(1) Feeding tube 8FR. 15" long (4) with UF(1) tube suction connection Drape utility with belt. Y." X 12' UF(2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IVEO sterile surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customized has been confirmed to exist Catalog numbers (multiple batches) with different possibilities of packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Vein Bag-(1) Standard large SMS Velcro/Neck (3) LAP for dress. Sponge pre-washed XRD LIF(1) limb board ABS LIF(1) package 36" X 36"(1) IMP. STOCKINETTE 14" X 48" LIFEO Sterile Surgical Convenience Bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29th, 2014; Customized by Inc-D & C Laparoscopy Package-(1) No vent tube air injection opening tip (1) MAYO bracket cover reinforcement UF (4) Hanging practical UF (1) Tray MAYO small living body (1) Specimen container 4 ounces. With lid and label(1) Suture bag flower LIF(1) Tube suction connection X" X 12' LIF(1) Syringe 10cc without needle LUER lock LIF(2) Tights 30" X 42" LIF with 7" cuffs (1) A practical bowl of 32 ounces. UF(1) *FOLEY catheter 5CC/2 way 16FR silicone coated latex (2) The dressing is not ADH TELFA 4 X 3 ST. UF(1) Jelly lubrication 5 grams (1) Table cover reinforcement 50" X 90" LIF(1) *Pk. STERI Striped Knee Sleeve Kit Latex(1) Cover camera, with elastic UF(2) Large SMS impermeable reinforcement UF(4) Towel absorbent 15" X 20" UF(1) Hanging knees. Perineal belt bag 102" X 97" soft SMS UF(2) hood(1) dressing TEGADERM 4" X 4 %" LIF(10) gauze sponge 4" X 4" 16-layer XRD UF(1) protective clothing. Reinforced X large towel/wrap (1) scalpel weighted safety #11 (1) bag zipper lock (1) Pk. STRIP STERI close W'X 4" LIF(1) Timeout beacon non-woven fabric ST. UF(1) Bandage gauze elasticity 4"(1) ULTRA VERES 120MM UF(2) Counter NDUBLADE; 10C MAG/CLEAR UF(1) SKIN MARKER INK 8 LABEL! TIME OUT/RULER L/FEO Convenient packaging for sterilization surgery, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12'(1) 30cc syringe without needle ULOCK (1) basin ring (1) TU Y kit; 2 wires; ST. (1) Overlock suture flower (1) Surgical gown. REINF. XL extra-long grade IV (2) Towel clip (1) Drape LITHOTOMY W/LEGGIN I POUCH UF 11 0" x 63" (2) Sheet 41" X 58" SMS(1) Cover sheet reinforcement 50" X 90" (1) Bag catheter 2000ML anti-reflux (3) Towel absorbent 15" X 20" ( 1) Robe IMP. SMS EXTRA REINF. XL T/WRAP Class IV (1) 4 ounce container specimen with lid and label (1) Time-out beacon non-woven ST.EO sterile surgery convenient packaging, packaged with Tyvek In a polyester/polyethylene breathable bag with double vents. The customer has determined that there is a possibility that the integrity of the package may be compromised due to different catalog numbers (multiple batches). This may result in product contamination or loss of sterility State and cause harm to the patient.

Customized on August 29th, 2014; Customized by Inc-Universal Packaging-(1) Tray organizer full depth (1) Anesthesia spinal needle 22G X 3 ~ UF (1) Syringe 5cc without needle LUER lock UF (1) Syringe 10cc no Syringe with needle (1G HYRING LUER) X 1 ~ UF(2) IMPERVIOUS enhanced X-Large SMS AAMI Ill(1) Sheet with adhesive 108" X 77" STD SMS LIF(1) Sheet% 57" X 63" reinforced SMS LIF(2) Towel 15 absorbs "X 20" LIF(4) Drape practical LIF(1 0) Gauze sponge 4" X 4" 12PL Y LIF(4) Buhak towel blue LIF(1) Table cover reinforcement 50 "X 90" UF(1) With scalpel handle #11(1) Denture cup with lid(1) Tray 2 Compartment(2) Suction head applicator(1) Impermeable glue 14" X 48" LIF(1 ) Tape TRANSPORE 1" X 36" (1) X DIISP needle 30 ~(1) Probe hanging 6" X 96 with gel(1) Arterial needle 18 X 2 %(1) Catheter introducer 7FR(1) Needle and blade Counter 10c MAG/CLEAR L/FEO sterile surgery convenient packaging, packaged in polyester/polyethylene with Tyvek double vent breathing bag. Customed has determined that the packaging integrity may be due to different catalog numbers (multiple batches This may cause harm to the patient due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Retina Packaging-(1) Table cover reinforcement 44" X 78" LIF(50) Cotton tip applicator 6" wooden lifebuoy (2) Extra large reinforced version of impervious robe (2) Medicine cup 2 ounce lifebuoy (5) Towel 15" X 20" LIF(1) Universal eye mask (1) Eye mask (1) Disposable bipolar cable (1) Ophthalmic bipolar pencil (10) Gauze sponge 4" X 4" 16PLY (2) Eye pad 2 1/8 X /8 ST. (1) MAYO support cover enhanced life cycle (1) Knife 15 5.0 controlled depth. (1) Needle and blade counter 20C foam/magnetic LIF (1) Surgery Blade #15 stainless steel (3) 15 syringes. X 5/8 SLIP TIP L/FEO sterile surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined a different catalog number ( Multiple batches) packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-OPHTALMIC PACK- (1) Table cover reinforcement. 44" X 78" UF (1) Dress SMS XLGE STD UF(2) Towel absorbent 15" X 20" LIF (1) Syringe 3cc with 0 NDL LILOCK UF(1) MAYO support cover reinforcement. LIF (1) Needle 18G X 1% ST. UF(10) Eye Microsponge UF (2) Label Contrast Blue (1) LGE STD SMS (1) Wipe Instrument 1 mm (1) Eye Mask UF (1) Label for Medication Mocaine Yellow (1) Iodine Poly Vitone 1. (1) Eye Mask Universal L/F(10) Applicator 6" Wood(1) Balanced Salt Solution 18ml LIF(10) Gauze Sponge 4" X 4" 12P Y UF (1) Label BSS(1) Tray 3/Compartment LIF (1) LABEL EPINEPHRINE VIOLET/WHITE(1) LABEL IODINE WHITE/BLACK Product use: EO sterilization operation convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that the integrity of the packaging may be affected on different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Breast Pack-FJG; Code 900-3118; Contains: (2) Long robe size standard SMS AAMIIII (2) Towel absorbent 15" X 20" (1) Pencil cautery Push bottom (1) Syringe bulb 60CC (1) Tube suction connection ~" X 12' (1) and counter blade 20C foam/magnetic (1) Bowl practical TIY quart 32 ounces (1) Lid Mayo bracket reinforcement (2) Skin Marker with ruler (2) Ruler (1) Cover table reinforcement 50" X 90" (2) Cup denture with 8 oz tooth cover (6) Terry cloth HUCK blue (2) Syringe 20CC without needle LUER lock (1) YANKAUER straw without vents (1) Drape breast/chest SMS (10) Sponge pad pre-washed 18" X 18" SHEET% (1) Drape enhanced 60" X 77" (4) Drape utility tape (1) Blade Surgery. #15 Carbon Steel (2) PR. Glove SURG. CUSTOMGUARD CHLOROPRENE # 6.5 POWDER FREE (2) PR. Glove GUARD SURGLO CUSTON CROUSTON. Powder-free (1) PR. GLOVE SURG. CUSTOMGUARD Chloroprene # 7.5 Powder-free (10) Gauze sponge 4" X 4" 16PLY(1) PK. Strip-like sterile closure W'X 4"(1) Needle spinal anesthesia 322Y 1) Needle 22G X 1Y2(1) IV Primary add-on management kit(1) Cock 3WAY WSIVEL male (1) Syringe 60ML without needle Luer lock Product use: EO sterile surgical convenient bag, packaged in a polyester/polyethylene breathable bag, with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customized – ORTHO PACK EXTREMITYCUSTOMEDCONTENTS: (1) Table cover reinforcement 50"" X 90"" (1) MAYO support cover reinforcement (1) Stitched bag flower (1) STOCKINETTE IMPERVIOUS 14"" X 48""(1) -DRAPE 60"" X 70"" WfTAPE SPLIT (1) Sheet end ABS. 125"" X 85""(1) GOWN SOFT SMS STD. XLGE SET IN SLEEVE(1) Package 24" "X 24""(1)) TOWELS ABSORBENT 15"" X 20"" Product use: EO sterile surgery convenient bag, packaged into a polyester/polyethylene breathable bag, with Tyvek double vents. Customized has been confirmed, different catalogs No. (multiple batches) packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-liposuction package BOD; code 900-3028; contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill(2) LITE gloves L​​IF(2) Towel absorbent 15" X 20" L/F(1) needle 27G X 1 %" LIF(1) bowl 2 ounces 3 quarts(1) COVER MAYO STAND REINFORCED L/F(1) PVP scrub solution 4oz(2) skin marking ink with 8 labels/timeout/ruler LIF(2) case reinforcement 44" X 78" LIF(1) cup-shaped denture 8oz blue green with lid(12) terry cloth HUCK C blue LIF(1) safety scalpel #15 once LIF(2) Syringe 10CC without needle LUER Lock LIF(1) Peristaltic peristaltic pump (4) Clamp(3) SLIFE LIF "X 100" LIF Product use: Convenient packaging for EO sterilization surgery, packaged with Tyvek In a polyester/polyethylene vented bag with double vents. The customer has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may result in contamination of the product or loss of sterility and cause damage to patients harm.

Customized on August 29, 2014; Inc Customed – LAPAROTOMY PACK – (I) UTILITY BOWL 16oz (I) ELECTRODE DUAL DEPRES./GROUNDPAD(I) UTILITY BOWL 32oz (I) GOWN IMP. Enhanced XL SMS AAMI Ill (2) Needle and blade counter I OC MAG/transparent (I) Drape abdominal belt bag (2) Towel absorbent 15" x 20" (I) Time-out beacon non-woven fabric (4) Drape practical () Skin marking ink with 8 labels/timeout/ruler (I) Enhanced Mayo bracket cover (I) Suture bag flower (I) Table cover reinforcement 50" X 90" (I) Robe IMP additional reinforcement LGE TOWEUWRAP (2 ) SHEET 42" X 55" SMS (I) CAUTERY TIP POLISHER(I) CAUTERY PENCIL ROCKER SWITCH (I) BAG GLASSINE(I) SURGICAL BLADE# 10 STAINLESS STEELEO Convenient packaging for disinfection surgery, packaged with custom Tyvek double exhaust It has been determined that the packaging integrity of different catalog numbers (multiple batches) in the polyester/polyethylene breathable bag may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-PREMIUM CESAREAN PACK-CUSTOMED-(1) BABY BLANKET IMP. 30" X 30" polymer absorbent(3) Towel absorbent 15" X 20" LIF(1) Bowl plastic 80 oz with lid(10) Knee sponge pre-wash XRD LIF(2) Pad obstetrics X Big ST.( 1) COVER MAYO bracket reinforced LIF(1) Suspended piece 41" X 58" SMS LIF(1) pipe suction connection. X" X 12' LIF(1) Ear ulcer syringe 2oz LIF(1) YANKAUER suction tube without exhaust LIF(1) Umbilical cord clamp LIF(1) Dressing island 4" X 10"(1) Blade surgery #10 Carbon Steel 1) Blade Surgery #20 Carbon Steel (1) Reinforced 50" X 90" LIF(1) C-type Laparotomy with bag (1) Tight-tight gown X Large SMS AAMI III(1) Surgical gown. Enhanced surgical gown III TOWEL WRAPEO sterile surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has confirmed that the packaging of different catalog numbers (multiple batches) is complete Sex may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Shoulder Bag; Code 900-2616; Contains: (2) TUBE SUCTION CONNECT Y."X12′ UF (1) Syringe 20CC W/0 NDL UL UF (2) Pendant video camera UF (1) Guemeo support reinforcement. UF(5) Sponge pad. Pre-washed XRD UF (1) DRAPE U 60" X 70" WIT APE UF(1 0) Gauze sponge 4" X 4" 16PL Y XRD UF ( 1) DRAPE BEACH CHAIR SHOULDER UF (1) CO BAN WRAP 4"X5 YRD latex (1) dress kid. XTRA REINF. X-LGE UF(1) TUY SET 81" 2.1M REG. CLAM (1) GOWN IMP. POL YREINF XLGE T/WRAP UF(1) Table cover REINF. 50" X 90" UFProduct Usage: EO disinfection operation convenient package packaging In a polyester/polyethylene breathing bag with Tyvek dual exhaust ports. The customer has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause damage to patients due to product contamination or loss Sterile state causing injury.

Customized on August 29, 2014; Customized by Inc-Laparoscopy Package--(1) MAYO bracket cover reinforced LIF(2) Overhang% ECONOMY 53" X 77" LIF(1) tube suction connection. vi" X 12' LIF(1) Scalpel with handle #11(1) Hanging knee and abdomen with bag 1 02" X 122" X 78" LIF(1 0) Gauze sponge 4" X 4" 16-layer XRD LIF(8) Towel absorbent 15" X 20" L/F(1) Reinforced table cover 50" X 90" L/F(1) *Laparoscopic wound closure latex(1) Pendant laser camera with /EL 6" X 96" LIF(4) Drape practical with L/F tape(3) Water-impermeable gown X-Large SMS L/FEO Sterilization operation convenient packaging packaged in polyester/ with Tyvek double vents Different catalog numbers (multiple batches) in polyethylene vented bags that customers have determined that the integrity of the packaging may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Laparoscopy~OBPACK-(4) Absorbent towel 15" x 20" LIF(2) Leg guard with 7" cuff (1) Laparoscopy T form SMS(1) Syringe 20cc Needleless LUER Lock LIF(1) XPODEREDLE1 1%(1) *ROBIN Red Glue Tube 14FR Latex(1) Pendant Laser Camera with Cover and LIF(1) Pad Obstetrics X Large 6" X 96" LIF(3) Towel clip (4) Draping instruments with cover and LIF (1)) Surgical gown POLY enhanced breathability IMP Large IV(2) Surgical gown POLY enhanced breathability IMP XL SMS LEVEL IV(20) Gauze sponge 4" X 4" 16 layers XRD LIF(1) 1" X90 MAYO bracket cover reinforcement LIF(1) Surgical blade #15 Carbon steel(1) LITE gloves L​​IF(1) Dressing non-adhesive TELFA 4" X 3"(1) TUBE SUCTION CONNECT Y4 "X 12' LIFEO Sterile Surgical Bag Customed Polyester/Polyethylene Breathable Bag with Tyvek Double Vents It has been determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may be due to the product Contamination or loss of sterility can cause harm to the patient.

Customized on August 29, 2014; Inc Customed-Abdominal Wrinkle Removal and Liposuction Pack; Code 900-2661; Contains: (1) DRAPE% ECONOMY 53 X 77(3) GOWN SOFT SMS Standard X-Large Set in SLEEVE(3 ) TOWELS ABSORBENT 15 X 20(1) MAYO STAND COVER REINFORCED(1) Reinforced tablecloth 50 X 90) Suture bag flower(6) Towel cloth HUCK blue(1) Blade surgical carbon steel 10(1) Blade surgical carbon steel 11( 4) Abdomen pad 8 X 7.5(1) CAUTERY TIP POLISHER)(YIP POLISHER) Suction tube without vent(20) Sponge prewash 18 X 18 XRD(1) Cauterizing pencil rocker switch with holster(1) Backing plate 23 X 36(1) tube suction connection 1/4 X 12(1) cloth strip SMS Product use/ :EO sterilization surgery convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents . Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Intravascular Packaging; Code 900-2715; Contains: (I) Suspended Femoral Horn. 125 X 75 X 56 LIF with bag(2) Towel absorbent 15 X 20 LIF(I) Container sample 4 ounces with lid and label Llf(2) Bag with fluoroscope 36 X 30 LIF(I) Needle 1 Low temperature; LIF (2) Dress large SMS IMPERVIOUS enhanced AAMI III LIF(2) Solution DURAPREP 6ML LIF(I) Wrap with friction belt and tape 42 X 38 LIF(4) Towel Buhak blue LIF(I) Pr. Gloves SYNTEGRA CR 6.5 powder-free Llf(2) Pr. Gloves SYNTEGRA CR 8 POWDER FREE LIF(I) Needle injection 25G X 5/8 LIF(I) Syringe 30CC Without needle LUER Lock LIF(I) COYER Table 44 X 90 LIF(I) Scalpel with handle(25) 4 12-layer LIF(2) Towel clip(2) Syringe I OCC Needle-free LUER lock LIF(I) Needle HYPODERMIC 18G XIY; LIF(I) SHARP STOP NEEDLE HOLDER LIF(I) TRAY ORGANIZER FULL DEEP(I) NEEDLE 18G X 23(I) BOWL UTILITY BLUE 16oz LIF(I) WRAPPER 24X 24 LIF Product use: EO ethylene is sterilized into a breathing bag with Tyvek double vents for convenient surgical operation. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Universal Packaging-(1) Table cover reinforcement 50" X 90" LIF(3) Towel absorbent 15" X 20" LIF(1) MAYO bracket cover reinforcement LIF(1) tube吸连接。 Suction connection. X" X 12' LIF(1) YANKAUER suction tube without exhaust LIF(1) Bag stitch thread(1) 100" X 53" LIF(1) with adhesive on top of suspension X 71" with tape LIF 1) Cautery head polisher LIF(3) Surgical blade #1 0 Carbon steel (15) Knee sponge prewash XRD LIF(1) Bag of glass glue (2) Hanging side with adhesive 36 "X 77"(2) Needle and 1 blade count MAG/CLEAR L/F(1) LITES GLOVE LIF(3) Surgical blade #15 Carbon steel(1) Specimen container 4 oz, with lid and label(1) Packaging 24" X 24"(3) Surgical gown SMS polyethylene reinforcement. BREATHABLE IMP XLGE AAMI IVEO sterile surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customized has determined different catalog numbers ( Multiple batches) packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – ARTHROSCOPY PACK – -(1) MAYO STAND COVER REINFORCED LIF(3) TOWELS ABSORBENT 15" X 20" LIF(1) STOCKINETTE IMPERVIOUS 14" X 48" LIF(1) Syringe 20cc No needle tube (1) Surgical blade # 11 stainless steel (1) needle 21G X 1 ~ LIF(1) TUY SET 81" 2.1M conventional clam (1) needle 18G X 1 ~ (1) sheet arthroscopy (with 1 time X Wire mirror inspection) 0) Gauze sponge 4" X 4" 16PL Y(1) Sheet 70" X 100" LIF(1) *Pr. SURGEON Neutral Glove #8 Latex(2) Anti-seepage reinforcement of robe X Large SMS(1) 0) Gauze 4" X 4" 16PL Y XRD LIF(1) Pipe suction connection. X" X 12' LIF(1) U-DRAPE 60" X 70" with tape bifurcation 6" X 21"(1) DURAPREP SURGICAL SOLUTION 26ML LIF( 1) Needle spinal anesthesia. 18G X 3 %" LIF(2) elastic bandage 6" X 5 years old. LIF(1) Table cover reinforcement 50" X 90" LIF(1) Pad abdomen 8" X 7.5"(1) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEXEO Sterile operation convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Open Heart Pack; code 900-2618; contains: (9) DRAPE 60" X 76" reinforced LIF (1) MAYO bracket cover reinforced LIF (6) towel absorbent 15" X 20" L/F(1) Table Cover BTC 77" X 110" HD Full Coverage LIF( 1) MAYO TRAY Large (8) Hanging and practical WfTAPE LIF(1) Table cover reinforcement 44" X 78" LIF(2) GOWN SURG. SMS POLY-REINF Breathable AAMI IV X Big T/WRAP (1) Suspended split aerobic exercise with transparent Anest. SC STD SMS(1) SHEET SPLIT BILATERAL 84" X 80" LIF Product use: EO sterilization surgery convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – KNEE ARTHROSCOPY PACK 4CUSTOMEDCONTENTS: (1) COVER TABLE REINFORCED 50"" X 90""(1) GOWN SURG REINFORCED LARGE TOWEL WRAP AAMI LEVEL Ill (1) PRE PAD FOAD CUFF( 1) COVER MAYO STAND bag stitched flower (1) Piece split tape/adhesive 108"" X 77"" STD SMS(1) STOCKINETTE IMPERVIOUS 12"" X 48"" (4) Strip 24"" X 4" "(1) Pendant arthroscopy W /POUCH (1) TOWEL ABSORBENT 15"" X 20"" Product use: EO sterile surgery convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Plastic Surgical Pack-(1) MAYO Stent Cover Reinforced LIF (1) Cautery Tip Polisher LIF (1) Bag Suture Flower L/F (1) YANKAUER Suction Tube, No Row Air LIF(20) Gauze sponge 4" X 4" 4PL Y(1) Reinforced cover 50" X 90" LIF(2) Robe impervious to water and reinforced large SMS(1) Pencil sharpener manual switch L/F(1) The tube attracts the connection. ~; X 12' LIF(1 0) LAP Sponge Pre-Wash XRD LIF(2) LITE GLOVE LIF(4) HUCK CLOTH TOWEL BLUE(2) Medium size 41" X 69" LIF(2) Needle and blade counter 1 OC MAG /CLEAR LIF(1) Hanging knee and abdomen bag STD SMS(5) Pk. STERI strip closed %"X 4" L/F(1) magnetic device. DRAPE(3) Skin marker with ruler life cycle(1) Lengthened electrode blade(2) Absorbent towel 15" X 20" LIF(4) UTILITY BOWL 32 oz(2) Surgical gloves #8 BIOGELEO vinyl sterilization to convenient poly Breathing bag with Tyvek double vents in ester packaging. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Customized Laparoscopy Convenience Pack includes multiple components: dress; tablecloth; needle and blade counter; bag stitching; stitching; sponge/gauze; container; syringes 20cc and 30cc without needles; needles ; Drape; pipe; towel; dressing island; and blade surgery SS.EO sterile surgery convenient packaging packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has been determined, different catalog numbers (multiple batches) ) The packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – ARTHROSCOPY PACK – (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE Sponge 4" X 4" 16PL Y XRD LIF(1) TUBE SUCTION CONNECT ~" X 12' LIF ( 1) Sheet ARTHROSCOPY T STD SMS POUCH LIF(1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) Syringe 20cc without needle Luer lock L/F(1) Blade Surgical #11 Stainless Steel(1) Needle 22G X 1G Needle needle 18 needle X 3 Y2 LIF (1) Abdomen pad 8" X 7.5" LIF(2) Elastic bandage with Velcro 6" X 5yds LIF (1) Timeout beacon non-woven LIF(1) Needle 18G X 1 Y2 L/F (1)) Skin Marking Ink Band 8 Label/Timeout/Scale LIF(1) Cover Sheet 44" X 90" LIF (1) Counter NDLIBLADE 20C Foam/MAG L/F(3) Towel Absorbent 15" X 20" LIF (1)) Bag stitching flower (1) Single layer cloth sheet 70" X 100" SMS LIF (1 0) Gauze sponge 4" X 4" 16PL Y(1) Solution Surgical DURAPREP 26ML LIF (1) ) Protective clothing IMPERVIOUS EXTRA LIF (1) TUR Y suit 81 inches 2.1 million pieces of conventional clams LIF level unsuitable towel/wrap LIF(1) U-DRAPE 60" X 70" with bifurcation 6" X 21" UF(1) Robe XL SMS IMP ERVIOUS REINFORCED AAMILEVEL Ill LIFEO Sterile operation convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – BASIC COSMETIC SURG. PACKCUSTOMED (USA); CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15"" X 20"" LIF (1) Overhanging breast/chest SMS L /F(1) Syringe 20cc W /0 Needle Luer Lock LIF (1) Tube suction connection Yt"" X 12' LIF(1) YANKAUER SUCTION TUBE W/0 VENT L/F (1) STERI STRIP CLOSURE%"" X 4"" L/F(1)) Blade SURG. #15 carbon steel(1) Needle subcutaneous injection 25 X 1% LIF(5) Knee sponge prewash 18"" X 18"" XRD LIF(1) Pencil type cautery rocker switch with leather case LIF (1) B ccR continuation ring CATH. TIP LIF (1) Table cover reinforced 50"" X 90"" LIF (1) Cover MAYO bracket reinforced LIF (1) Bag Suture flower (2) Robe soft SMS STD.XL sleeved on the sleeve LIF (4)) Drape with L/F tape practical (4) Terry cloth HUCK LIF (1) Packaging 24"" X 24"" Product use: EO Convenient packaging for sterilization surgery, packaged in a polyester/polyethylene breathable bag with Tyvek dual vents.” Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – REYITO UROLOGY PACK – (2) GOWN IMP. Reinforced super large SMS (2) Towel absorbs UF(I) urinary tube. Bag 2000 ml anti-reflux UF (I) syringe 30cc W/0 NDL. LUER LOCK UF(I) Bag suture(I) Table cover(I) Pipe suction connection. W'X 12' UF (10) Gauze sponge 4" X 4" 16PLY(I) EMESIS basin(I) Pendant laser camera W / E(I) Practical bowl 32 ounces (I) Bowl plastic 80 ounces with lid (I) Syringe IOcc W/0 NDL. LUER LOCK UF (I) Syringe IOcc pre-filled gel (5) Container sample 4 ounces with lid and Gel label(I) SURG. REINFORCEDT/WRAP X-LARGE(I) TUY SET; 2LEAD UF (I) DRAPE LITHO 11 0" X 63" WI POUCH WILEGGING(I) ROUND WASH BASIN 6QT.EO Sterile operation convenient package Packed into a polyester/polyethylene respirator bag with Tyvek double vents. Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may result in product contamination or loss of sterility State and cause harm to the patient.

Customized on August 29, 2014; Customized by Inc-E..NT packaging-(5) Sponge tonsils 7/8 XRD(1) Table cover reinforcement 50" X 90" LIF(1) MAYO Support cover reinforcement L/F(1 ) Tube suction connection %" X 12 ′ L/F(1) CAUTERY TIP POLISHER LIF(1) Suture bag flower(2) Container specimen with lid and label 4oz(1) Cauterizing pencil manual switch(2) Absorbent towel 15" X 20" L/F(1) Overhanging piece 41" X 58" SMS L/F(1) Ear/ulcer syringe 2oz LIF(2) Medicine cup 2oz(1 0) Gauze sponge 4" X 4" 16PL Y(1 ) *Pr. Surgical Gloves #7% POWDER(1) *Pr. SURGICAL GLOVES #7 POWDER(9) Skin MARKEREO Sterile surgery convenient packaging label, packed in a Tyvek double vented polyester/polyethylene breathable bag In. Customd has determined that packaging integrity may be affected by different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Basic Packaging-(1) Table cover reinforcement. LIF(1) MAYO support cover reinforcement. LIF(2) Towel absorbent LIF(10) Gauze sponge XRD 4" X 4" 12PLY(2) Hanging sheet 41" X 58" SMS(4) Drape practical WIT APE L/FEO Sterile operation convenient packaging, packed in poly Tyvek double vented bag in ester/polyethylene respirator. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29th, 2014; Customized by Inc – PERY GYN bag- (1) practical drape with UF tape (1) hip drape with bag (2) absorbent towel 15" x 20" UF (2) with 7" Leggings with cuffs 30" X 42"(1) Table cover reinforcement 50" X 90" UF (1) Abdominal belt UF(1) Utility bowl 16 oz. (1 0) Gauze sponge 4" X 4" 16PL Y XRD UF(1) Pad Obstetric XL LIF (2) Specimen Container 4 oz. With lid and label (1) Syringe 1 Occ pre-filled with gel (1) Suspended piece 41" X 69" Medium UF(1) catheter 14FR. Grab. .NELAT (1) Non-adhesive Telfa dressing (2) Gown IMP. Enhanced LGE SMSEO sterile surgical convenience bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customized has been confirmed, different catalog numbers The packaging integrity (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – Customed Angiodrape Pack Convenience Pack includes multiple components: syringe 10cc and 30cc; gauze; denture cup; specimen container; bag; gloves; gown; needle hypodermic injection; absorbent towel; tablecloth; Scalpel; Buhak towel; Iodopovidone; smear sponge; towel clip; femoral angiography drape; needle 18G; and GuidewireEO sterile surgical convenient packaging, packaged in polyester/polyethylene breathable with Tyvek double vents Customized in the bag has been determined, and the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – LAPAROSCOPY CHOLE PACK – -( 1) STRIP STERI ClosURE W'X 4" LIF( 1) Table cover reinforcement 50" X 90" LIF( 1) Overhanging knee and abdomen W/POUCH 102" X 122" X 78" (2) GOWN LGE SMS anti-seepage reinforcement LIF(1) GOWN XL SMS anti-seepage reinforcement L/F(5) towel absorbent 15" X 20" LIF(5) knee sponge pre-wash 18" X 18" XRD LIF (4) APE LIF(1) Protective cover camera with elastic LIF(2) Gauze sponge 4" X 4" 12PL Y LIF(1) ULTRA VERES 120 mm LIF(2) Cover cloth 41 "X 58" SMS LIF(1) Scalpel with safety belt #11(1) Tube inflatable open end with 0 vent (1) Dressing TEGADERM 4" X 4 %" LIF( 1) Tube suction connector X "X 12' LIF(1) MAYO support cover reinforcement LIF(1) suture BAG FLORAL LIF(1) Pk. STERI strip LAP set latex(1) rope laparoscopic monopolar LIF(1) MAYO tray small LIF(1) ) Time-out beacon non-woven fabric ST. LIF(1) Skin marking ink with 8 tags/RULER LIF( 1) BAG ZIP LOCK PLASTIC 6" X 10" EO sterilization operation convenient bag, packaged in a polyester/polyethylene bra Her Tyvek Customized bag with double vents has been determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-liposuction kit; code 900-2681; contains: (3) GOWN SOFT SMS STD XLGE set in the sleeve (1) tube suction connector (1) MAYO bracket cover reinforcement (1) ) Skin marking ink W label(2) Table cover reinforcement 50 X 90(1) RULER 6 Transparent( 12) Towel Buhak (blue)(1 0) Knee sponge pre-wash 18 X 18 XRD(1) Burning head Polisher(20) Gauze sponge 4X 4 12PL Y(4) Towel clip(1) Y connector(1) Pencil clamp BOTTOM(3) Overhang piece 98 X 63 STD SMSProduct Purpose: EO sterilization surgery convenient bag, packed in belt In a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – Tummy Tuck Pack; code 900-2684; includes: (3) GOWN SOFT SMS STD XLGE set (1) CAUTERY PENCIL PUSH bottom (1) tube suction connection (1) MAYO bracket cover Reinforcement (1) Skin marking ink W label (2) Table cover X50X00 (1) RULER 6(6) TOWEL CLOTH HUCK (BLUE)(10) LAP SPONGE PREWASH 18 X 18 XRD( 1) CAUTERY TIP POLISHER(1) DRAPE BREAST /CHEST SMS product use: EO sterilization operation convenient packaging, packaged in polyester/polyethylene with Tyvek double vent breathing bag. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – LUMBAR PACKADVANCED AMBULATORY SURGICAL CENTERCONTENTS: (1) Cover Table Reinforced 50"" X 90"" UF (4) Syringe 3CC without needle LUER lock UF (8) Towel cloth Gram 10CC with NERLUE LUE LUTH LOCK UF (10) Gauze sponge 4"" X 4"" 16PLY XRD UF (1) Strip STERI DRAPE LARGE 17"" X 23"" UF(1) Scalpel with handle #11 ( 1) COVER FLUORO 30"" X 30"" with rubber strap UF (1) Drape bra 100"" X 142"" X 72"" (1) Ruler flexible plastic (1) Solution SURGICAL DURAPREP 26ML UF (1) Piece Material: X 60"" X 77"" draped reinforced type UF (1) Strip STERI closed %" X 4"" UF (2) GOWN SOFT SMS STD. XL set on sleeve UF (4) Needle 18G X 1% U (1) Skin marker tape ruler UF (1) Needle-shaped subcutaneous 25 X 1% UF (1) Dressing TELFA 8"" X 3"" non-ADH UF (1) Dressing TEGDERM 4 X 4%"" UF (1) STERI -STRIP compound benzoin tone 2/3cc VIALL /F (1) Bag zipper lock UF (9) Skin marking label UF Product use: EO sterilization surgery convenient bag, packaged in polyester/poly with Tyvek double vents In a ventilated vinyl bag. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc" Customized-LITHOTOMY Package Content: (2) Absorbent towel 15"" X 20"" (2) Tights with 7" cuffs 30"" X 42"" CSR (1) Pleated Lower buttocks with pouch 44"" x 35""(1) with tape 40"" X 54""(1) taped belly (1) table cover reinforcement 50"" X 90""(1) timeout beacon Non-woven fabric ST. Product use: EO sterilized packaged in a polyester/polyethylene breathable bag with Tyvek double vents for surgical convenience. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Advanced Laparotomy Package-Customized-(1) DRAPE T LAPAROT 102" X 78" X 121"(1) GOWN XL SMS IMPERVIOUS REINFORCED(1) COVER TABLE REINFORCED 50" X 90 "LIF(1) STAND STAND REFORCED LIF(4) Draping utility with tape LIF(4) Towel absorbent 15" X 20" LIF(5) Sponge pad pre-wash 18" X 18" XRD LIF(1) YANKAUER pump Suction tube W/0 VENT LIF(1) Tube SUCTION CONNECT~~~ X 12′ LIF(1) Surgery blade #10 Carbon steel (1) Surgery blade #15 Carbon steel (1 0) Gauze sponge 4" X 4" 16PL Y XRD LIF(2) Surgical drape 42" X 55" LIFEO sterile surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-the dress is impermeable; code 900-3190; Contains: GOWN IMPERVIOUS EXTRA LARGEWITH TOWEL & WRAP Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Liposuction Pack FJG; Code 900-3115; Contains: (2) GOWN Big SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) Towel absorbent 15" X 20" LIF (1) Needle 25 X 1 LIF(1) BOWL Utility QUART 32oz LIF(1) REIN MAYOFAND (20) Gauze sponge 4" X 4" 16PLY LIF(1) Reinforced cover sheet 44" X 78" LIF(2) Cup-shaped denture 8 oz blue Green LIF with lid(6) Terry cloth HUCK Blue LIF(1) Safe scraper #15 LIF(1) Syringe 10CC without needle LUER lock LIF(4) Practical drape, with L/F(1) piece% drape reinforcement 60" X 77" LIF(1) PR. Glove surgery. CUSTOMGUARD neoprene #7 P/FL/F(2) PR. GLOVE SURG CUSTOMGUARD Neoprene #6.5 P/FL/F(1) Hanging top with adhesive 108" X 50" STD SMS L/F(1) Hanging bottom ABS REINF. 71" X 62" STD SMS with tape L/F(2) hanging side 42" X 76" with tape LIF(1) PVP iodophor bottle 4oz paint (1) straw 8'X 3/8" ID non-conductive life ( 1) STRIP STERI CLOSURE Y2" X 4" Product use: EO sterilization surgery convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that different catalog numbers (multiple) may be The integrity of the package is affected due to product contamination or loss of sterility, which may cause injury to the patient.

Customized on August 29, 2014; Inc" Customized-Buttocks bag content: (2) Towel absorbent 15"" X 20"" (2) GOWN XL SMS IMPERV.REINFORCED (1) MAYO STAND COVER REINFORCED (1) Suture bag (1) Draping utility with tape (1)) STOCKINETTE IMPERV. 14"" X 48""(1) U-DRAPE 54 X 72 WITH TAPE SPLIT HIP DRAPE 89"" X 128"" WITH POUCH TABLE COVER REINFORCED 50 ""X 90""Product use: EO sterilized surgical packaging is convenient packaging in a polyester/polyethylene vented bag with Tyvek double vents"Customed has been determined, and the packaging of different catalog numbers (multiple batches) is complete Sex may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Minor Pack 900-2511; The package contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII(10) GAUZE Sponge 4" X 4" 16PLY XRD(5) LAP Sponge PREWASH 18" X 18" XRD(1) DRAPE LAPAROTOMY W/POUCH x 4" x 16PLY" 124"(4) Practical hanging with tape(2) Hanging piece 41" X 69" medium size(1) MAYO reinforced bracket cover(1) Robe SURG XLGE Reinforced Towel and Wrap AAMIIII (1) Blade Surgical Steel (10# Stainless Steel) Mask (1) Burning Pencil Rocker Switch (1) Table Cover Reinforced 50" X 90" (1) Practical Bowl Blue 16 oz (1) Towel absorbent 15" X 20" (1) The solution is convenient for surgical operation. 6 ML is packaged into a polyester/polyethylene breathable bag with Tyvek double breathable holes. Customed has been confirmed, different catalog numbers (multiple The packaging integrity of each batch) may be affected. This may result in product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Customized labor and delivery package-including: (1) Table cover 44" x 90" (2) Leg cover/7" cuff 30" x 42" (5) Absorbent towel 15" x 20" LIF(1) Baby blanket printing LIF(2) Pad obstetric XLGE LIF(1) Ear ulcer syringe 2 oz LIF(1) Baby blanket ABS. IMP. LIF(1) Pr. Surgical gloves# 7Y2( 1) Lower hip towel (1) BEANNIES BABY LIF(1) Feeding tube 8 Fr. 15" long LIF(1) Abdomen cloth sheet 41" X 58" SMS(1) GOWN SURG with tape L/F(1). Enhanced X Large SMS Level IV(1) Vaginal Sponge XRD(1) Umbilical Cord Clip LIF(2) Buhak Towel Blue(1 0) Gauze Sponge 4" X 4" 16-layer XRD LIF(1) Syringe 1 Occ Band LE 21 X 1 Y2(1) MUCUSTRAP 20cc 1 OFr.(1) Plastic bowl 80 ounces with lid(1) Packing 24" X 24" LIFEO sterile operation convenient packaging, packed in polyester/polyethylene breathable bag with Tyvek Double vents are the package integrity may be compromised due to different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29th, 2014; Inc Customized-Surgical suit soft SMS non-enhanced; code 900-2725; contains: (1) GOWN SOFT SMS STD X-Large SET IN SLEEVE(1) TOWEL ABSORBENT 15" X 20"(1) WRAPPER 24" X 24" Product use: EO sterile surgical convenient bag, packaged into a polyester/polyethylene breathable bag Tyvek with double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Caesarean section package- (1) BEANNIES BABY LIF (1) Desk cover enhanced version 50" X 90" LIF (1) Cover MAYO bracket enhanced version LIF (3) Sheet 41" X 58 "SMS LIF(5) Towel absorbent 15" X 20" LIF(15) Sponge pad prewash 18" X 18" XRD LIF(1) YANKAUER suction tube W/0 VENT L/F(2) Anti-needle and blade 10c MAG/CLEAR LIF(2) Pad Obstetric X-Large LIF(1) Injection Ear/Ulcer 2 oz. L/F(1) BABY PRINTED (1) TUBE SUCTION CONNECT Y-1" X 12' LIF(1) Syringe 20cc W/0 NEEDLE LUER LOCK LIF(1) Blanket receiving 100% cotton(1) Bowl with lid plastic 80 Oz. (1) Umbilical cord clamp (1) Pipe PVC 8FR 15" long (1) Robe X large SMS impervious reinforcement LIF (1) Bag suture flower (2) Glove medium non-contact VYNEL POWDER / handle #1 0( 1) Scalpel with handle #20 (2) The bowl is useful for 16 ounces. LIF(1) PVP Paint 8" Stick Sponge LIF(1) GOWN SURG Enhanced X Large Towel/Wrap LIF(1) Pencil Burning Manual Switch LIF(1) Scissors Umbilical Cord 4.5" Straight(1) Package 24" X" (1 ) PVP SCRUB 8" STICK SPONGE LIF(1) DRAPE C-SECTION W/POUCH 102" X 121" X 78" LIF(1) TIME OUT BEACON NON WOVEN LIFEO Sterilization operation convenient bag, packed in polyester/polyethylene breathable bag Double vents in Tyvek. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "customized-secondary packaging content: (1) Absorbent towel 15"" X 20"" (1) Wrapping paper 24"" X 24"" (16) Gauze sponge 2"" X 2"" 8PLY (1) Semi-shallow tray (12) COTION TIP applicator 6"" WOOD (2) GLOVE SKY NITRILE PF BLUE MED(18) Gauze sponge 4"" X 4"" 12PLY (1) Small hanging tape ADH Product use of perforated bag: EO sterilization surgical convenience package is packaged in a polyester/polyethylene vented bag with Tyvek double vents.” Customed has determined that the package integrity of different catalog numbers (multiple batches) may be affected. affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-hip and knee joint replacement kit; 900-2614; contains (1) CAUTERY TIP POLISHER UF(1) BAG SUTURE FLORAL(1) TUBE SUCTION CONNECT Y." X 12' UF (1) Reinforced table cover 50" X 90" UF(1) MAYO Reinforced UF(5) Towel absorbent 15" X 20" UF(2) Overhanging sheet 70" X 100" L/F(5) Knee Sponge pre-wash 18" X 18" XRD LIF(1) Skin nail 35 Long life(1) MAYO tray large(1)) Top curtain with adhesive 100" X 50" SMS STD L/F(1) Bulb syringe 60cc(1) Utility bowl 16oz(1) Utility bowl quart 32oz(1) Incision curtain 23" X 17" mark(1) With skin RULER(1) U-DRAPE 60" X 70" with TAPE SPLIT 6 X 21(1) YANKAUER Suction tube without Vent UF(1) MERLING SKIN PREP APPLIC. 39ML UF(1) Scalpel#10 Stainless steel (stainless steel) split 108" X 77" UF(1) *Gloves# 7.5 SURGEON Neutral Latex(1) * GLOVE # 8 SURGEON NEUTRALON Latex(1) *Gloves# 8.5 SURGEON NEUTRALON LATEX(3) Degreasing XLINTRAIM (3) GOWN) Dress impermeable super strong towel and wrap(4) Practical shawl belt UF(1 0) Gauze sponge 4" X4" 16PL Y XRD LIF(2) Bandage elastic band VELCRO 6" X 5yds(1) Surgical blade # 20 stainless steel(2) LITE GLOVE UF(1) STOCKINETIE IMPERVIOUS 12" X 48"(1) CAUTERY PENCIL ROCKER SWITCH UF(1) XANDAGE ESMARK Product Usage: 6" EO sterile surgery convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customized has been confirmed, different catalog numbers (multiple Batch) packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-CATARACT PACK- OJOS INC.- (1) Table cover REINF. 44" X 78" L/F (2) Medicine cup 1oz. (2) Absorbent towel 15" X 20" LIF (1 0) Eye spear micro sponge (1) Eye pad 2 1/8 X 2 5/8 LIF ( 4) Drape practical LIF (1) Universal goggles (2) Long gown LGE Standard SMS Velcro/Neck (1) MAYO bracket protection cover REINF. LIF(1) Eye mask LIF(1) Syringe 3cc W/0 NDL L/LOCK LIF (1) Wipe instrument 1mm L/FEO Convenient packaging for sterilization operation, packed in a polyester/polyethylene breathable bag with Tyvek double vents middle. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized Inc-Laparoscopy Package-(1) APPLIER MULTI CLIP WITH SHAF GUN L/F(1) NEEDLE ULTRA VERES 120MM LIF(1) TROCAR Endopath XCEL DiLATING TIP (K11LT) LIF(1 ) TROCAR EndoTING.XCEL LIF(1) IMPERV. XTRA REINFORCED XL T/WRAP AAMI III(1) MAYO support cover reinforced LIF(5) Sponge pad pre-washed 18" X 18" XRD LIF(1) Container sample 40Z. The LIF(1) bowl with lid and label is 16 ounces. LIF(1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF(1) Pendant laser camera with 6" X 96" LIF(1 0) gauze sponge 4" X 4" 16-layer XRD LIF(4) Drape practicality and tape LIF(4) Towel absorbent 15" X 20 "LIF (1) Endoscopic Surgical Sheet 100" X 123%" X 77" Slotted L/F(2) Sheet 42" X 57" SMS LIF(1) Surgery Blade #11 Stainless Steel (1) Overtime Beacon None Woven fabric ST L /F(6) Gauze sponge 2" X 2" 4PL Y LIF(1) Blade surgery. #15 Carbon steel(1) Robe XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF(1) Table cover reinforcement 50" X 90" L/F Purpose: Convenient packaging for EO sterilization surgery, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected Affected. This may cause harm to the product to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Universal Packaging-Content: (4) Absorbent towel 15" x 20" LIF(1) MAYO holder cover reinforced LIF(1) Needle and blade counter 20c foam/MAG LIF(2) A practical bowl of 16 ounces. LIF(1) GLASINE BAG PLAIN(1) Suture bag flower(4) Draping utility tool with tape LIF(1) Reinforced 50" X 90" LIF(1) Surgical blade# 10 Stainless steel(1) 26mL SURAEPTION LIF (1) ) Laparotomy T Drape STD SMS(2) Drape piece 41" X 58" SMS LIF(2) Robe impermeable strengthening X Large SMS LIF(1 0) Gauze 4"X 4" X 4 layers(1) Cautery tip LIF( 5) Knee sponge pre-washed XRD LIF(1) Burning pencil rocker switch LIF(1 0) Gauze sponge 4" X 4" 16-layer XRD LIF(1) pipe suction connection. 3/16" X 12' LIF( 1) Surgery Blade# 15 Carbon Steel( 1) Container Specimen 4 oz. With lid and label Product use: EO sterilized surgery convenient packaging packaged into a polyester/polyethylene breathable bag with Tyvek double vent customization has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – Laparoscopic Gallbladder – (6) Towel absorbent 15" X 20" LIF(1) MAYO support cover reinforcement L/F(1) Syringe 3cc needle-free LUER lock LIF(1 ) Surgical blade #11 carbon steel TU Y SET; 2LEAD L/F(4) drape utility, with tape LIF(1) TROCAR Endo. XCEL Expansion Tip 5mm (K5LT)(1) ULTRA VERES Needle 120mm(1) Needle and Blade Counter 20C Foam/MAG LIF(1) Hanging knee. abdomen. With bag 102" X 122" X 78"(2) Hanging piece 41" X 58" SMS(2) Anti-seepage enhancement of robe X Large SMS LIF(10) Gauze sponge 4" X 4" 16PLY XRD L/F(5) LAP SPONGE PREWASH XRD LIF(1) Pendant laser camera W/EL. 6" X 96" LIF(1) Tube suction connection. 3/16" X 12' LIF(1) TROCAR Endopath XCEL Expansion tip 11mm (K1 1LT) (1) Pipe inflation kit W/0 ring adapter LIF(1) SURGICAL DURAPREP SOLUTION 26ML LIF(1) Table cover reinforced 50" X 90" LIF Product use: EO sterilization surgery convenient packaging, packaged in polyester/polyethylene breathable In the bag, with Tyvek double vent customization, it has been determined that the integrity of the package may be affected by different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Caesarean section package-(1) Imported baby blanket. Poly ABS. (4) Absorbent towel 15" x 20" LIF(2) Needle and blade counter 10C MAG/transparent LIF (2) LITE gloves L​​IF(1) Bowl plastic with lid 80 oz. (1) Caesarean section with bag 102" X 121" X 78" (1) Practical bowl 32 ounces (10) Knee sponge pre-washed XRD LIF (2) Pad obstetric XLGE (1) Baby beans (1) MAYO support cover reinforcement L/F (1) Suspended piece 41" X 58" SMS LIF(1) Tube suction connection. X" X 12' L/F (1) 2oz ear ulcer syringe. LIF(1) Receiving blanket 100% COTION (1) YANKAUER SUCT TUBE without ventilation L/F(1) Umbilical cord clamp(2) 20"X 20"(1) Dressing island 4" X 10" (1) SCALPEL# 10 With handle S/S(1) Scalpel# 20 With handle(1) Reinforced 50" X 90" L/F(1) MAYO tray small(1) MUCUSTRAP 20cc 1 OFr.(2) Robe LGE SMS anti-seepage reinforcement (1) SURGICAL DURAPREP SOLUTION 26mL L/F Product use: EO sterilized surgical convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that packaging integrity may be affected by different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-customized laparotomy package; convenient package includes multiple components: drape peritoneum. Robe; absorbent towel; scrubbing; stock sponge/gauze; table cloth; drape; suture bag; duraprep surgical fluid; Buhak towel; practical bowl; straw; scalpel; mayonnaise tray; mayo cover; & lite gloves. EO sterile surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents, Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Orthopedic Package I (2) Customized; 900-2503; Contains: (2) Towel absorbent 15" X 20" LIF (1) Cover MAYO bracket reinforcement L/F (1) U-DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF(1) DRAPE% ECONOMY 53" X 77" LIF(4) DRAPE UTILITY WIT APE LIF(1) Pouch suture flower LIF(1) Split belt Adhesive 1 08" X 77" LIF(1) Cover plate reinforcement 50" X 90" LIF Product use: EO sterilization operation convenient packaging, packed in a polyester/polyethylene breathable bag with Tyvek double vents . Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Advanced Arthroscopy Package-Customized-(1) Arthroscopy lens T with bag LIF (1) Waterproof STOCKINETTE (3) Ribbon tape 24" X 4" (1) Tape separation (2) Towel X 105" "LIF(1) GOWN IMPERVIOUS enhanced X-Large SMS(1) GOW SURG. Reinforced large towel/wrap (1) Table cover reinforced 50" X 90" LIF(1) MAYO Stand cover reinforced LIF(1) Container specimen 4 oz with lid and label (1) Tube suction connection. }4" X 12' LIF(1) Surgical blade #11 carbon steel (1 elastic bandage 6" X 5 YRD. L/FEO sterile surgical convenient bag, packaged in polyester/polyethylene breathable with Tyvek double vents In the bag. The customer has determined that the integrity of the package may be compromised due to different catalog numbers (multiple batches). This may cause harm to the patient due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Plastic Surgical Pack-Label Sample Content: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF(10) Gauze sponge 4" X 4" 16-layer LIF (1) Table cover 44" X 90"(1) Surgical drape 70" X 100" LIF (2) Scalpel blade #15 S/steel (1) Scalpel WIT APE 44" X 26" LIF (30) COTION TIP APPLIC 6" WOOD LIF(1) PVP PAINT 8" STICK SPONGE(1) NEEDLE & BLADE COUNTER 20C FOAM I MAG L/FEO Sterile operation convenient packaging, packed in Breathing bag with Tyvek double vents in polyester/polyethylene. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Angiography Package-(1) LINE HP 1200 PSI 48" M/F(1) ANG. Femoral Cover Cloth Bag UF(1) Platform Tray Large (3) Syringe 10cc None Needle LUER FOLOCK LIF(1) Round steel cover 50" X 90" LIF(2) Bag blanket and tape UF(2) Syringe 20cc Needle-free Luer lock LIF(5) Absorbent towel 15" X 20" LIF(1) Syringe 30cc Needleless LIFICAL LUER (1) DURAPREP SOLUTION 6ML LIF(1) Safety scalpel #11 stainless steel (2) Dress standard SMS Large Velcro neck (1) Manifold with control syringe (1) Needle 18G X 2% AMC/4(2) WL utility tool 12 oz Buhak towel blue(2) needle 21 GX 1 ~ LIF(2) medicine cup 2oz LIF(30) gauze sponge 4" X 4" 16PL Y(1) needle 18G X 1 ~(4) Towel syringe 3cc without needle Luer lock LIF(1) HALSTED MOSQUITO CVD 5" serrated (2) Syringe 5cc without needle LUER LOCK L/F(2) Needle HYPODERMIC 22G X 1EO Sterile surgery Bag/polyethylene breathing bag vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – CIRUGIA CARDIOVASCULAR – CASE CART -(1) CIRUGIA CARDIOVASCULAR (PREPARACION)(1) CIRUGIA CARDIOVASCULAR (ENFERMERA CIRCULANTE)(1) CIRUGIA CARDIOVASCULAR (INDUCCION)(1) CIRUGIA CARDIOVASCULAR (INDUCCION)(1) (1) Open polyethylene/cardiac surgery bag with Tyvek double vent. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-PERY GYN bag- (1) Draping utility with tape (1) Draping base cloth with bag (1) Towel absorbent 15" x 20" UF (2) Base Trousers 7" Cuffs 30" X 42"(1) Table COVER REINFORCED 50" X 90" UF(1) DRAPE ABDOMINAL WITH TAPE UFEO Sterilization operation convenient bag, packed in polyester/polyethylene breathable bag with Tyvek double Vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – Laparoscopy Package – (1) Tracheal Inflatable Bag Set W/0 Ring Adapter LIF(1) Endoscopic Surgical Sheet 1 00" X 123W' X 77" Slotted (1) ) MAYO Support Cover Reinforcement LIF(4) Towel 5" X 20" LIF(4) Cover Utility Tool with Tape LIF(5) Gauze Sponge 2" X 2" 4PL Y(1) Rope Laparoscopic Food Switching Monopole(1) ) Scalpel weight safety #11(1) Solution SURGICAL DURAPREP table cover reinforcement 50" X 90" LIF(2) LITE glove UF(1) Suture bag flower UF(1) Needle and blade counter 20c Foam/MAG LIF(1 ) Practical bowl 32 ounces. (2) Sheet X 42" SMS(1) Pendant laser camera W/EL 6" X 96" LIF(5) Tape TEGADERM 2 3/8 X 2 o/. UF(5) Knee sponge prewash 18 inches X 18 inches XRD L/F(2) Robe SURG SMS Polyester fiber reinforced breathable impermeable sleeve AAMI IV grade critical zone X Large(1) Dress SURG SMS L/F impermeable Membrane IV CRITICAL ZONE X Large towel/WRAPEO sterile surgical convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-AV Fistula Bag- (1) DRAPE T LAPAROT 102" X 78" X121" STD SMS(3) GOWN SURG.REINFORCED X-Large EXTRA LEVEL IV(1) DRAPE SHEET 42" X 57" SMS(4) DRAPE Utility with TAPE LIF(1 0) GAUZE Sponge 4" X 4" 16PL Y XRD LIF(1) Pencil CAUTERY Hand SWITCHING LIF(1) TUBE SUCTION CONNECT "Y-1" X 12' LIF (1) FRAZIER with Control VENT & OBTUR 10F LIF(2) LITE GLOVE LIF(1) BOWL Utility 32oz LIF(2) BOWL Utility 16oz LIF(10) LAP Sponge PreWash XRD LIF(1) Solution SURGICAL DURAPREP 26ML LIF(3 ) 60 Syringe with lock (1) Syringe 30CC without needle LUER lock UF (1) Syringe 5CC with needle 21G X 1% LUER lock UF (2) Syringe 3CC without needle LUER lock UF (1) Needle 18 needles and 1 % BLADENEDLE 10C MAG/CLEAR UF(1) Lid MAYO bracket reinforcement LIF(1) Lid table 44" X 90"(1) MAYO tray small (2) Absorbent towel 15" X 20" UF(1) Bowl with lid plastic 80ozEO Convenient packaging for surgical sterilization, put in a polyester/polyethylene breathable bag with Tyvek dual vents. Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This May cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Universal Packaging-(1) Practical bowl 16 ounces. (1) Needle spinal anesthesia. 22G X 31! 2(1) Syringe 5cc without needle LUER lock LIF(2) Syringe 10cc without needle LUER lock LIF(1) Syringe 30cc without needle LUER lock LIF(1) Needle G2N10GOWDER (2)-Large SMS not Permeable enhanced AAMIIII(1) split board with adhesive 108" X 77" SMS STD LIF(1) Overhang% ECONOMY 53" X 77" UF(2) Towel absorbent 15" X 20" with RAPEPE UF( 4) D tape LIF(1 0) gauze sponge 4" X 4" 12PL Y(4) Towel Bukhak blue(1) Table cover reinforcement 50" X 90" UF(1) Scalpel with handle #11( 3) PK. ClosURE SKIN W'X 4" STERI Strip UF(1) Skin Marker with Ruler(1) 8oz Denture Cup with Lid(1) Needle 25 X 1 1! 2(1) STOCKINETTE IMPERVIOUS 14" X 48"(2 ) TIP ABSORB. APPLICATOR STICK SPONGE(1) TRAY ORGANIZER FULL DEEP(1) TRA 2/COMPARTMENT(1) RULER L/F Product use: EO sterilization surgery convenient bag, packaged into a polyester/polyethylene breathable bag with Tyvek dual vents. Customed has determined that packaging integrity may be compromised due to different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customized-Laparoscopy Package I (4) CUSTOMEDCONTENTS: (1) Towel absorbent 15"" X 20"" LIF (2) Tights W/7" Cuff 30"" X 42"" LIF (1) DRAPE UTILITY WITAPE L/ F(1) FLORAL LIF(1) SHEET T LAPAROSCOPY SOFT 97"" X 96"" X 36 LIF""(1) Reinforced table cover 44"" X 78 "" L/F product use: EO sterilization surgery convenient bag is packed in a polyester/polyethylene breathable bag with Tyvek double vents. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-customized main laparotomy package; convenience package includes multiple components: Mayo stent cover; absorbent towel; bag suture; drape; straw; light glove; gauze/sponge; drape; surgical blade ; Practical bowl; towel; straw; cauterization technique; gown; and label. EO sterilization surgery convenient packaging is packaged in a polyester/polyethylene breathable bag with Tyvek double vent Customed. It has been determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc" Customized-Face Pack Cosmetic Surgery Cosmetic Surgery Content: (15) Applicator 6"" WOOD(60) Gauze sponge 4"" X 4"" 16-layer soft LIF (2) Needle LIFLS (22G X 83 Y2 TOWE) CLOTH HUCK BLUE LIF(2) Syringe 10CC without needle LUER lock LIF (6) Blade #15 Carbon rib (1) Piece ENT SPLIT 110"" X 77"" SMS L/F (3 ) *Pr. GLOVE PERRY SURG # 7. Latex (5) Sponge pad pre-washed 18"" X 18"" XRD LIF (1) Cover plate reinforcement 50"" X 90"" LIF (2) COTTON BALL MED(3) *Pr. GLOVE PERRY SURG # 7 Latex(1)) DRAPE INST. Magnetic 10"" X 16"" L/F(2) Needle 30G X 1 DISP LIF(1) Marked skin with ruler LIF(4) Skin marking Label 1.25 X Y2(1) Anti-pin and blade 15 FOAM I MAG STRIP LIF (2) GOWN SOFT SMS STD X-LGE SET IN SLEEVE LIF(1) RULER 6"" FLEXIBLE(1) BAG ZIP LOCK 6"" X 10 "" PLASTIC product use: EO sterilization surgery convenient packaging polyester/polyethylene breathable bag with Tyvek double vents." Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – Tummy Pack MRT; Code 900-2657; Contains: (2) GOWN SOFT SMS STD XLGE set (1) CAUTERY Pencil PUSH bottom (1) needle ULTRACLEAN 1" (2) syringe 10cc Needleless LUER lock (1) Needle and blade counter (1cFOAM)/20MA BOWL UTILITY QUART 32oz(1) MAYO Reinforced bracket cover (1) Reinforced table cover 50" X 90"(1) Hanging chest cord SMS(1) ) Ruler 6" Transparent (6) Terry cloth HUCK C (blue) 152 ABS towels "X 20"( 1) TUBE SUCTION CONNECT ~" X 12'(1) Denture cup 8oz with lid (2) SKIN MARKER INK WITH 8 LABEL(2) LITE glove product use: EO sterilization surgery convenient packaging, packaged into a polyester/polyethylene respirator bag with Tyvek double vents. Customized has been determined, packaging with different catalog numbers (multiple batches) Integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-OB bag-(1) Baby blanket printing (1) Baby beanie (1) Reinforced table cover 50" X 90" LIF (2) LEGGINS 30" with 7" cuffs X 42" LIF(1) sagging cloth sagging/bag 44" X 35" LIF(3) towel absorbent 15" X 20" LIF(1) cover sheet 41" X 58" SMS LIF(2) pad obstetric X large LIF (1) receiving blanket 100% cotton (1)) PVP SCRUB 8" stick sponge (1) feeding tube BFR; 15" long life (1) bowl plastic 80 ounces with lid (1) umbilical cord clamp (1) syringe 20cc no Needle LUER Locking LIF (1) 20ml LIPSYRING (1) Tunic Large SMS Impermeable Enhanced LIF(1) Needle 18G X 1%(1) Needle 22G X 1%(20) Gauze Sponge 4" X 4" 16PL Y (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" LIF(2) GLOVE MED FREETOUCH VYNIL POWDER FREE(1) WRAPPER 24" X 24" L/F(1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL/WRAP LIFEO Conveniently packaged into surgical polyester/polyethylene breathable bags with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may result in product contamination or loss of Bacteria state and cause harm to the patient.

Customized on August 29, 2014; Customized by Inc-PERl GYN bag (1) table cover 44" x 90" (2) trouser leg band 7" cuff 30" x 42" (1) belly drape tape LIF (2) absorbent towel 15" X 20"(10)) GAUZE SPONGE 4" X 4" 16PLY (2) Dressing is not ADH TELFA 4" X 3"(1) ROBINSON RED CATHETER 14FR. (1) UNDERBUTTOCK DRAPE WITH POUCHEO Convenient packaging and packaging for disinfection surgery Vents in a polyester/polyethylene double-layer breathable bag. Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause patient contamination due to product contamination or loss of sterility harm.

Customized on August 29, 2014; Inc Customized-Advanced Urology Package-Customized-(1) Lithotripsy surgical drape with anesthesia bag. (2) Absorbent towel UF(1) MAYO support cover reinforced UF(1) Urinary bag 2000 ml anti-reflux (1.SURFUNF) Reinforced large T/WRAP(1) Practical bowl 32 oz. (1) Tubular suction connector. W'X 12' UF(1) Table cover reinforcement 50" X 90" UF(1) TU Y SET 81"2.1M Common clam ST.(1) Robe XL SMS impermeable reinforcement(1) Specimen container 4 ounces. With Lid & LABELEO sterile surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may be Injury to the patient due to product contamination or loss of sterile conditions.

Customized on August 29, 2014; Customized by Inc – Laparoscopic Cholecystectomy Package – (1) Laparoscopy/Abdominal UF (1) MAYO Stent Cover Reinforcement UF (1) Blade Surgery #11 Stainless Steel (1) Single Surgery 41" X 10" SMS GEUZE(1) "X 4" 16PL Y XRD UF (1) Pipe suction connection. 3/16" x 12' UF(3) Towel absorbent 15" X 20" UF (1) Robe IMPER. Extra reinforced LGE TIWRAP(1) Table cover reinforced 50" X 90" UF (2) Dress large SMS IMPERED (4) DRAPE UTILITY WITH TAPE UFEO Sterile operation convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customd has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. Affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – Face Pack FJG; Code 900-3116; Contains: (2) Long gown standard SMS AAMIIII (2) Towel absorbent 15" X 20" (1) Anti-needle and blade 20C Foam/MAG(1) Cover MAYO support reinforcement(1) Piece ENT SPLIT 11 0" X 77" SMS(1) Reinforcement cover sheet 44" X 78"(20) Gauze sponge 4" X 4" 12PL Y(6) Towel Buhak Blue (1) PK. STRIP STERI Closed WX 4"(2) Cup Denture 8 oz Cyan with Lid (1) Skin Marker with Ruler (1) Ruler (1) Syringe 10CC without Needle LUER Lock (1) Tablet o/. Drape 60" X 77 "Repacking 1) Blade SURG. #15 Carbon steel (1) Blade SURG. #10 Carbon steel (4) Draping utility with tape (1) Syringe bulb 60CC (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE/F 6 ) Prs. GLOVE SURG. CUSTOMGUARD neoprene # 7 P/F(1) Pr. GLOVE SURG. CUSTOMGUARD neoprene # 7.5 P/F(1) YANKAUER suction pipe, no exhaust port (1) pipe suction connection% ”X 12'(1) PENCIL PUSH BOTIOM HOLSTER Product use: EO sterilization operation convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Caesarean section package--(7) Towel absorbent 15" X 20" (2) Scalpel weighing safety #1 0(1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL Utility QUART 32oz. (1) Tube feeding 8Fr. 15 inches long (2) Anti-Needle/Blade 10C MAG/Clear (1) Peas Baby (2) Pad Obstetric XLGE ST. (1) Syringe 20cc with 0 needle LIL (1) Syringe ear/ulcer 2 oz (1) BLAN Receive 100% COTION (1) Clamp umbilical cord ST. (1) Enhanced version 50" X 90" (1) Syringe 10CC with 0 needle L/lock (1) Bowl plastic with lid 80 ounces (2) Robe XL SMS IMPERVIOUS enhanced (1) Flake overhang 41" X 58" SMS (1) Overhang C part W/POUCH 102" X 121" X 78"(1) YANKAUER SUCTION TUBE W/0 VENT (1) Package 30" X 30"( 15 ) Foam ring pre-washed 18" X 18" XRD (1) Timeout beacon non-woven ST. (1) Tube straw ECT~" X 12' (2) Lens hood (1) GOWN SURG REINF large T/WRAP( 2 ) PK. STRIP STERI ClosURE W'X 4"(1) POLISHER CAUTERY TIP (1) DRESSING COMP OP 4" X 14"(1) Cover MAYO Enhanced Edition (1) Skin Marking Ink W/8 Label/Timeout/ RULEREO None Convenient packaging for bacteria surgery is packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that the integrity of the package may be affected and compromised with different catalog numbers (multiple batches). This may be due to product contamination. Or lose sterility and cause harm to the patient.

Customized on August 29, 2014; Customized by Inc-FOLEY catheter kit 1118FR.- Customized EDCONTENTS: (1) Package 24" X 24" (1) Label ID Patient (1) Tray Organizer (1) PVP Triple Swab Iodophor (2) Gloves MED FREEILTOUCH/V 1) Jelly lubrication 5 grams (1) Towel 3PL Y POLY 17" X 18" (2) SWABSTICK dry cotton (1) Hanging 4" opening 18" X 26" (1) Catheter FOLEY 18FR; 2 way 10ml silicone oil coating 1) 2000ml anti-reflux UF(1) Specimen container 4 ounces with lid and LABELEO sterile surgery convenient packaging, packaged in polyester with Tyvek double vent In a polyethylene breathable bag. The customer has determined that there may be packaging integrity issues. Product catalog numbers are different (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized – HIP PACK I (2); Customized; Code 900-2504(1) Surgical gown. Reinforced XLGE Towel/Wrap (1) MAYO Support Cover Reinforced (1) U-shaped fold 60" X 70" with tape bifurcation (1) STOCKINTE IMPERVIOUS 12" X 48" (4) Drape utility tape (1) ) Bag stitching 1) DRAPE HIP 89" X 128" reinforced with adhesive (1) Cover sheet reinforced 50" X 90" Product use: EO sterilization operation convenient packaging, packaged in polyester with Tyvek double vents /Polyethylene breathable bag. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-shoulder arthroscopy bag; code 900-2719; contains: (1 0) gauze sponge 4 X 4 12PL Y(1) COBAN WRAP TAN 4 X 5yds(3) PAD ABDOMINAL 8 X 7.5(1) Dressing 1 X 8 XEROFORM PETROLAT(1 0) Gauze sponge 6PL Y4 XRD(1) Needle 18G X 1 (1) Needle spinal anesthesia 18G X 3 W(1) Needle 22G X 1 W(1) Syringe 60ML No With needle LUER lock (1) Blade cover. 11 Carbon steel (1) Skin marking with ruler (9) Skin marking label (4) PR Glove SURG. DERMA PRENE POWDER FREE(8) Terry cloth HUCK BLUE(2) U – DRAPE 60X 70 WIT APE SPLIT 6 X 21(1) SHEET 60 X 77 DRAPE Reinforced(2) SOLUTION SURGICAL DURAPREP 26ML (STUNE) CONNECT watch cover reinforcement 50 X 90(1) Ruler(2) Surgical gown reinforced X large(1) Surgical gown reinforced X large towel/wrap(2) Towel absorbent 15 X 20(2) X plastic bag 1226ml 1) Shoulder arthroscopic surgery drape(1 ) Filtering straw 5 MICRO(1) Practical bowl 16oz(1) STOCKINETTE IMPERV 9 X 48(2) LITE GLOVE Product use: EO sterilization operation convenient packaging, packaged into a polyester/polyethylene breathable bag with Tyvek double breathable holes. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Heart-shaped tray-Packaging-(25) Sponge pad pre-washed 18" X 18" XRD L/F (1) TRAY PLATO L/F (3) DRESSING Non ADH TELFA 8 X 3 (2) BAG GLASSINE PLAIN(2) YANKAUER suction tube without exhaust LIF(1) Reinforced cover 50" X 90" LIF(1) Needle 27G X'h" (4) Anti-needle and blade 10c MAG/CLEAR(2) Syringe 20cc without LIFLUER (LIFLUER)) Can 16 oz 500ml scale (2) Syringe 30ml without NDL Luer lock L/F (2) Pencil burning manual switch LIF(1) Mark the skin Ruler (2) Bandage elastic 4" X 5yds LISHERIP (2) 2) Bandage elastic 6" X 5yds LIF(2) Syringe bulb 60cc transparent (2) Tube suction connection Yt" X 12' LIF(1 0) Gauze sponge 4" X 4" 16-layer XRD LIF (1) Needle needle 3.0 mm (2) Container sample 40z. With lid and label (1) ALL ARROUND with sharp blade (1) Pelvic vomiting 10 inches 700cc (3) Catheter 20FR ROB NEL RED RUB (3) Bowl utility quarter 32 ounce CATHOLIFTER 32FR straight (1) label set; heparin; saline; etc. (2) safety scalpel #10 DISP (3) basin cleaning wheel 6QT (2) safety scalpel #15 DISP(2) bowl practical 16 oz L/F(1) packaging 54" X 54" L/F(1) connector Y 3/8" X 3/8" X 3/8" EO sterilization operation convenient packaging In the polyester/polyethylene breathable bag with Tyvek double vents, Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may result in product contamination or loss of sterility And cause harm to the patient.

Customized on August 29, 2014; Customized by Inc-CARPALTUNNELLARGE-(1) Table cover 50" X 90" enhanced life cycle (1) Syringe 10cc without needle LUER lock life cycle (1) Practical bowl 32 oz life cycle (2 ) Curtain fabric 41" X 584" SMS short sleeve" elasticity (1) Needle hypodermic injection 25G X 5/8"(1) STOCKINETTE 6" X 48" LIF(2) Buhak towel blue (1) Dress SMS large No. non-reinforced towel/cloth wrap(1) gown surgical guard/scarf wrap(1) needle 18G X 1%"(10) gauze sponge 4" X 4" 16PLY XRD LF(1) practical bowl 16 oz LIF(1) Absorbent towel 15" X 20" LIF(1) cast pad surgical blade #15 stainless steel (4) drape practical, with L/F(1) piece end ABS. 125" x 85" SMS EO sterile surgery convenient packaging, packaged in In a polyester/polyethylene vented bag with Tyvek double vents. Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may be harmful to patients due to product contamination or loss of sterility Cause harm n.

Customized on August 29, 2014; Inc Customized-Implant Orthopedics-1) The gown IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF(1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF(1) Tube suction connection. Y.!" X 12′ L/F (1) CAUTERY Pencil ROCKER SWITCH LIF(2) *Pr. SURGEON NEUTRALON GLOVE# 8 Latex(2) Blade surgery# 10 Stainless steel(1) Pouch glass(1) STOCKINETIE IMPERV “X 48"LIF(2) LITE GLOVE LIF (1) Split sheet with adhesive 108" X 77" STD SMS UF(1) MAYO Support cover reinforcement LIF (4) Hanging utility and tape LIF(5) Absorbent towel 15" X 20" LIF (5) LAP Sponge Pre-wash XRD LIF(2) Hanging Sheet 70" X 100" STD SMS LIF (1) MAYO Tray Large(2) * Pr. SURGEON Neutral Glove #8% Latex(1) Staple Food SKIN WIDE 35 ST. LIF(1) Top drape with adhesive. 108" X 50" STD SMS LIF (1) Bulb syringe 60cc(2) Elastic bandage 6" X 5"yds LIF (2) Practical bowl 32oz(1) Practical bowl 16 oz LIF (1) Skin marking with ruler (1) Incision drape antibacterial 23" X 17" LIF (2) Abdomen pad 8" X 7 W(1) U-shaped cord 60" X 70" WIT APE SPLIT 6" 21 feet (2) robe IMPERVIOUS REINFORCED XL(1) YANKAUER SUCTION TUBE WITHOUT VENT UF (2) Cover Table BTC 77" X 86" HD FULL COVERAGEEO sterile surgical convenient packaging, packaged in polyester/polyethylene with Tyvek Double vent vented vinyl bag. Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Caesarean section surgery kit- (1) Bed cover enhanced version 50" X 90" (2) Towel absorbent 15" X 20" (1) MAYO bracket protection cover enhanced version (1) Baby Blanket printing (1 0) Knee sponge 18" X 18" XRD(1) Plastic bowl with lid 80 oz. (1) Bag of glass glue (2) Needle and blade counter 1 OC MAG/transparent (1) Umbilical cord clamp (2) Light gloves (1) Bowl practical 32 oz 1) BOWL UTILITY 16oz (4) DRAPE UTILITY (1) Tube suction connect. 1!4" X 12'(1) TIP CAUTERY POLISHER(1) MUCUSTRAP 20cc; 10FR.(2) Hanging piece 41" X 58" SMS(2) Extra reinforcement for impermeable robe(1) Pencil sharpener rocker( 1) ELECTRODE DUAL DEPRES./GROUNDPAD(1) ​​C-type laparotomy with bag 102" X 121" X 78"(1) Ear ulcer syringe 2oz(1) Baby bean(1) Receiving blanket 100% cotton(2) Blade #10 STAINLESS STEELEO Sterile surgery convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – Open Heart Tray; Package A; Code 900-1196C; Contains: (1) Table cover reinforcement L/Free(1) CARDIOVASCU.LAR cut overhang L/Free(2) 3/ 4 ABS. Reinforcement sheet (1) Plastic sheet (5) Suspended sheet SMS (18) Buhak towel blue (4) Buhak towel white (1 0) Absorbent towel L/Free (4) Robe IMP. Breathable LGE. (3) MAYO bracket cover L/Free (2) IMPERV. STOCKINETTE(1) WRAPPER 54" X 54"(1) TRAY PLATFORM LGE(1) TABLE COVER HD L/Free(1) WRAPPER 24" X 24" Product use: EO sterilization surgery convenient package packaged into polyester/polyethylene Tyvek vented bag with double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Arthroscopy Bag; 900-2609; Contains: (5) LAP Sponge Pre-wash 18" X 18" XRD (1) Sheet Arthroscopy T STD SMS Bag (3) With 24" X 4"(1) U-DRAPE 60" X 70" with slit tape(4)) Towel absorbent 15" X 20"(1) MAYO bracket cover reinforcement(1) Pipe suction connection Y4" X 12 '(2) Elastic bandage with Velcro 6" X 5yds(10) Gauze sponge 4" X 4" XRD(1) 1) Merlin skin preparation. APPLIC 39ML(1) Casting padding cotton roll 2" X 4yds(1) Skin mark with ruler(1) Scalpel#11 Carbon steel(1) Robe SURG reinforcement LGE towel wrapping cloth(2) Robe IOUS XL2 hair surface reinforcement SMS GLOVE(1) STOCKINETTE IMPERVIOUS 12" X 48"(1) Table cover reinforcement 50" X 90" Product use: EO sterilization surgery convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that there is a possibility that different catalog numbers (multiple batches) may affect the integrity of the package. This may cause harm to the patient due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-chest bag TPSC; code 900-3431; contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-Large AAMIIII(4) Absorbent towel 15" X 20" LIF(1) Pencil burning push bottom LIF(1) Syringe 60ML Luer lock needleless L/F(1) Tube suction connection X" X 12' LIF(1 ) Anti-needle and blade 20C foam/MAG L/F (1) Cover MAYO bracket reinforcement LIF (2) Skin marking ink with 8 labels/timeout ruler LIF (2) Bowl practical QUART 32 ounces. (1) Cover sheet reinforcement 50 "90 inch LIF(1) Ruler LIF(4) Drape practical LIF(2) Syringe 10CC Needle-free luer lock LIF(1) YANKAUER straw without exhaust LIF(1) Drape breast/chest SMS LIF(1) Gauze 4.5"XX 4 1/8 YD 6PL YL/F(2) LITE gloves(5) Foam ring pre-washed 18" X 18" XRD LIF(1) Flake drape 42" X 57" SMS LIF(1) Flake drape 70" x 100" LIFProduct use: EO sterilization surgical convenience package, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customized has been determined, and the packaging integrity of different catalog numbers (multiple batches) May be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized – ORTHO implant surgery kit – (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" with TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ) ABDOMINAL PAD 8" X 7 Y: z"(1) suction tube connector. }4" X 12' (1) DURAPREP SURGICAL SOLUTION 26ml(1) Glass bag (1) YANKAUER straw without vents (2) LITE gloves (1) Split sheet with adhesive 1 08" X 77" STD SMS(2) Lid BTC 77" X 86" HD full coverage(1) STOCKINETTE IMPERVIOUS 14" X 48"(1) MAYO reinforced bracket cover(1) Diagonal hanging antibacterial 23" X 17"(5) Absorbent towel X 15" (1)) Robe IMPERV. Extra enhanced XL SMS TNI/RAP level IV (4) Shawl utility (1) Burning pencil rocker switch (5) Knee sponge prewash XRD (1) Robe IMPERVIOUS enhanced SMS X Large (2) X70DRA 100-inch STD SMS (1) Timeout beacon non-woven fabric (1) STAPLE SKIN WIDE 35 ST. (1) Skin marking ink with 8 labels/timeout/ruler (1) MAYO tray large (1) Needle and blade counter 20c foam/MAG (1) Adhesive on the top hanging. 100" X 53" SMS (1) Robe impermeable super strong towel wrap (2) Elastic bandage 6" X 5" size (1) Syringe 30cc without needle (1) Utility bowl 16 ounces (1) Needle 18G X 1Y2 (2) Practical bowl 32 ounces (2) Surgical blade # 10 stainless steel sterile surgical convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Urology Package-(2) Syringe 30ML sliding tip 1 ML LIF (2) GOWN SURG. Reinforced large towels and wrappers (1 0) gauze sponge 4" X 4" 12 layers (1) urinary bag 2000 ml anti-reflux LIF(1) table cover reinforced 44" X 78" LIF(1) 1610" XRAPE "SMS WITH LEGGINS(3) towel absorbent 15" X 20" LIF(1) TUY SET 81"2.1m common clam ST.(1) TUBE SUCTION CONNECT Y4" X 12' LIF(1) BAG SUTURE FLORALEO convenient packaging for disinfection operation In a polyester/polyethylene breathable bag with Tyvek dual vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – 08 PAD PACK II (2;3)CUSTOMEDCONTENTS: (3) TOWEL ABSORBENT 15"" X 20"" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET PLASTIC "" X 65"" (1) Hip drape/bag (1) Umbilical cord clip (1) Baby blanket 30"" X 30"" POLY ABSOR.IMP. (1) Packaging vagina XRD 4 "" X 36"" 8 layers (10) gauze sponge 4"" X 4"" 16PLY XRD (1) Draping belly WITAPE 40"" X 54""(2) Tights with 7" cuffs 30"" X 42 "" (1) Table cover reinforcement 44"" X 78"" (2) PAD OBSTETRICAL XL (1) Ear ulcer syringe 2 oz. Product use: Convenient packaging for EO sterilization surgery, packaged in a polyester/polyethylene breathing bag with Tyvek double vents. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – BASIC PACK 1 (Ill) CUSTOMEDCONTENTS: (1) Table cover reinforcement 44"" X 78"" (4) DRAPE UTILITY WffAPE(2) Towel absorbent 15"" X 20 "" (1) Suture bag flower (1) DRAPE SHEET 42"" X 57"" SMS(1) SHEET :X 57"" X 63"" REINFORCED SMS (1) MAYO STAND COVER REINFORCED Product Purpose: EO sterilization operation is convenient The package is packed with Tyvek into a polyester/polyethylene vented bag with double outlets.” Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-chest bag BOD; code 900-3029; contains: (2) GOWN X-Large SMS IMPERVIOUS REINFORSED AAMI Ill (2) towel absorbent 15" X 20" (1) pencil burn Push-bottom (1) Syringe bulb 60CC (1) Straw connector (2'" X)) Anti-needle/blade 20C foam/MAG(1) BOWL UTILITY QUART 32oz TURQ(1) Cover MAYO enhanced version(1) Skin marking ink , With 8 labels/timeout/ruler (1) Cover sheet enhanced version 900" X 1) Cup denture 8 ounces cyan with lid (1) Ruler (6) Terry cloth HUCK blue (2) Syringe 10CC without needle LUER Lock (1) YANKAUER straws without vents (1) Overhanging breast/chest (2) LITE EO sterile surgery convenient packaging, packaged in a polyester/polyethylene breathing bag with Tyvek double vents. The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to the patient, product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – REEMPLAZO DE RODILLA Y CADERACONTENTS:(6) TOWELS ABSORBENT 15"" X 20"" (I) PK. STRIP STERICLOSURE Y;"" X 4""(I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W /8 LABEIJfiME OUT/Ruler (I) Bag suture flower (2) Scalpel weighted safety# I0(I) STOCKrNETTE IMPERV 14"" X 48"" (I) Timeout beacon non-woven Cloth (2) Drape U 60"" X 70 ""WI TAPE SPLIT 6"" X 21"" (2) TUBE SUCTION CONNECT'/." X 12'(2) DRAPE INCISE antibacterial 23"" X 17"" ( 2) Mask (I) Needle spinal anesthesia 18G X 3 Y; (4) STR IPS tape 24"" X 4"" (I) GOWN IMP. XTRA REINF SMS XL T/W LEVEL (20) GAUZE SpongES 4"" X 4"" 16PLY(3) DRAPE'!. ECONOMY 53"" X 77"" (I) DRAPE UNDERBUTTOCK W/POUCI-1 44"" X 35""(I) DRAPE TOP WIADHESIVE 108"" X 50"" STD SMS (I) Anti-pin 60C foam strip/MAG strip (I) YANKAUER OPEN TIP CLEAR W/0 CIV (2) DRAPE SIDE 36"" X 77"" with ADl-1.(I) with adhesive 108"" X 77"" STD SMS (I) Syringe 60 ML UL with 0 needle (I) Polishing agent cauterization tip (I) Needle blunt filling 18G XIY; (2) Cover table BTC 77"" XII 0""l -ID full coverage (2) Glove surgery. DERMA PRENE #8 Powder-free (10) Sponge pad pre-washed 18"" X 18"" XRD (I) Cover MAYO holder with CSR 23"" X 54"" (I) BOWL UTILITY QUART 32oz. (3) Clip towel ( I) BOWL Utility PINT 16oz. (3) GOWN MICROCOOL IMP. XTRA LONG XL(3) Bandage elasticity 6" "X 5YRD WIVELCRO (I) MERL ING SKrN PREP APPLIC.39ML (2) PADDING CAST SOFT ROLL 6 X 4YRD (I ) MAYO TRAY LARGE product use: EO sterilization operation convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "customized-CYSTO TUR package basic code 900-2899. Content: (2) Tights with 7" cuffs 30"" X 42"" (1) Reinforced 44"" X 78 "" (2) Towel absorbent "" X 20"" (1) Robe XLGE SMS IMPERV. Enhanced AAMI LEVEL Ill(1) TUR CYSTO irrigation device 79"" Single(1) Timeout beacon non-woven ST(1) Bag stitched flower(1) Practical bowl 32 (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER(1) TURP CYSTO DRAPE WITH POUCH(1) GOWN IMPER EXTRA REINF LGE AAMI LEVEL Ill TOWEL & WRAP Product Usage: EO disinfection operation convenient bag is packed into a polyester/polyethylene respirator bag with Tyvek double vents. "Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – ARTHROSCOPY PACK – (1) SURGICAL DURAPREP SOLUTION 26ML LIF(1) ESMARK BANDAGE(1) ELASTIC BANDAGE 6" X 5yds LIF(1) Needle and blade counter 20C foam/MAG(1 ) TUBE SUCTION 2'NEXIF (1) Plate extreme ABS. 125" X 85" SMS(1) Pendant laser camera with EL(3) Towel absorbent 15" X 20" LIF(2) Container specimen 4 oz. With lid and Label(1) Baby blanket IMP. POLY ABS. LIF(1) Needle 20G X 1%”(10) Gauze sponge 4” X 4” 16PLY(1) Blade surgery #11 Carbon steel(1) Reinforced 50” X 90" LIF IMPERVIOUS STOCKINETTE(1) Sheet drape 42" X 55" LIF(1) Stitched bag flower LIF(1) U-shape drape 60" X 70" with tape cracking(1) MAYO support cover reinforcement LIF(2) Robe IMPERGIOUS LIF (4) Strip (1) Syringe 20cc needleless LUER LOCK LIF(1) GAUZE KERLIX 4.5 X 4.1 YO 6PL Y(1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL & WRAPEO Convenient polyethylene breathing bag packaging to surgery There are Tyvek double vents in the bag. d It has been determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-PERl GYN PACK- (1) 15" X 20" UF with UF(2) towel absorbent (1) Top cover cloth with sticky STD SMS(1) catheter NELATON ROB. 14FR.(2) Robe IMPERVIOUS with extra reinforcement XL(1) Under-cushion with pouch (2) Tights with 7" cuffs 30" X 42"(1) Table cover reinforcement 44" X 78" UF(1 0) Gauze (1 0) X 4" 16PL Y XRD LIFEO Sterile operation convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – PERY GYN bag-customized- (1) Abdomen drape UF(1) Towel absorbent 15" X 20" UF(2) Tights W/7" Cuff 30" X 42 "(1) Table cover reinforcement 44" X 78" UF(1) DRAPE UNDERBUTTOCK WITH POUCHEO Convenient packaging for sterilization and surgery, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customized has determined different catalog numbers ( Multiple batches) packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – IMPLANTE DE ORTHOPEDIA – (I) CAUTERY T IP POLI SHER LIF (I) BAG SUTURE FLORAL LIF(I) TUBE SUCTION CONNECT \14” X 12' LIF (I) BAG GLASSINE LIF (2) LITE GLOVE LIF (2)) Table cover 50" X 90" reinforced LIF (I) MAYO stand cover reinforced LIF (5) Towel absorbent 15" X 20" LIF (4) Drape practical with tape LIF Procedure (2) Drape sheet 70" XI 50" LIF) LAP sponge prewash 18" X 18" XRD L/F (I) MAYO TRAY LIF LIF(I) Drape top with adhesive LIF (I) Skin nail 35 WIDE LIF( I) Bulb syringe 60cc LIF (I) Utility kit 16 ounces L/F(2) Utility bowl 32 ounces L/F (I) Incision curtain 23" XI 7" L/F(I) Skin mark with ruler LIF (I) U-shaped curtain 54" X 72" with bifurcated tape 6" X 2 1" LIF(2) Abdomen pad 8" X 7.5" L/F (I) YANKAUER suction tube W/0 VENT L/F( I) DURAPREP SURGICAL SOLUTION 26ML LIF (I) Surgical blade # 10 stainless steel (I) SPLIT SHEET W/ADH 108" X 77"" STD SMS LIF (I) IMP. STOCKINETTE LIF(I) *Pr. SURGEON NEUTRALON GLOVE #7 ~ Latex (I) *Pr. SURGEON NEUTRALON GLOVE #8 Latex (I)) *Pr. SURGEON NEU TRALON Gloves #8 ~ Latex (I) Surgeon dress REINF. T/WRAP X-LARGE LIF(2) imported GOWN REINFORCED X-LARGE SMS LIF (I) pencil cauterization rocker switch LIF(I) surgical blade #20 stainless steel STEELEO sterile surgical convenient bag, packaged in a Tyvek double vent In a polyester/polyethylene breathable bag. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Dress Up-Customized-(2) Gloves MED. FREETOUCH VYNIL powder-free (I) dressing TEGDERM 3 Y2 X 4 Y2( I) Mask program yellow 80 mm HG L/F (4) Gauze 4" X 4" 4PLY( I) Alcohol preparation pad MED (I) CI-ILORASCRUB. SW6 (I) Label precautions (I) Hanging non-doors and windows. 18" X 26" UF(I) tape transportation: Y. X 18 LIF (I) WRAPPER 20" X 20" EO sterile surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Caesarean section package-(1) Imported baby blanket. 30" X 30" POLY ABS. (1) Needle and blade counter 60c Foam/strip magazine/strip LIF(1) Dressing island 4" x 10"(1) Caesarean section 71" x 125" LIF(2) Robe surgical reinforcement towel/wrap (10) Knee sponge prewash XRD LIF (1) Baby bean (1) Stainless steel No. 10 scalpel with handle (1) Cover cloth 42" X 57" SMS (1) Ears Ulcer Syringe 2 oz. UF(1) Receiving blanket 100% cotton(1) No. 20 scalpel with handle(1) DURAPREP surgical fluid 26ml UF(2) Absorbent towel 15" X 20" LF(2) Lite gloves UF(1) Plastic bowl With 80 ounces L. (1) Table cover reinforcement 44" x 78" LIF(1) Practical bowl 32oz(2) Mat X Large ST.(1) Package 30" X 30" LIF(1) MAYO bracket cover reinforcement LIF(1) TUBE SUCTION CONNECT Y." X 12' UF(1) MUCUSTRAP 20cc 1 OFR(1) YANKAUER SUCTION TUBE WITHOUT VENT UF(1) UMBILICAL CORD CLAMPEO Convenient packaging for disinfection surgery, packed in polyester/polyethylene breathable bag It has Tyvek double vents. It has been customized. It is determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Urology bag-(4) UF absorbent towel (2) surgical gown POLY-REINF. Breathable XL grade IV(1) Syringe 30cc without NDL Luer lock L/F(1) TUY set; 81 inches 2.1M common clams(1) Table cover 44" x 90" (1) Overhanging stone plate 11 0" X 63" Fence with bag/leggings (1) pipe suction connection. Y. "X 12' LIF (1) Washbasin round 6QT (1 0) gauze sponge 4" X 4" 16PL Y LIF (1) Bag type urinary tube 2000 ml anti-reflux LIF (1) Pendant laser camera with SY UF (1) 1 Occ with 0 NDL Luer lock UF (1) Practical bowl 32 ounces. (1) Gel syringe 10cc pre-filled (5) Specimen container 4 ounces. W/LID & LABEL L/F (1) WRAPPER 20 "X 20" L/FEO Sterilization Surgical Convenience Bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customized has been determined, and packaging integrity of different catalog numbers (multiple batches) may be affected Impact. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Customed OB Pack Convenience Pack includes multiple components: setting cover; absorbent towel; syringe for ear ulcers; cushion; umbilical cord clamp; washbasin; baby blanket; tablecloth; gauze sponge; syringe 10CC without needle and 10CC with needle; feeding tube; drape; tights with cuffs; sagging hips; gown; container with lid; mayonnaise tray; receiving blanket; Customed in Tyvek double-vented polyester/polyethylene breathable bags has been determined, and the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – HIGADO & PANCREA PACK – (1) Bag stitched flowers (2) YANKAUER straws, no vents (4) Draping utility with tape (6) Terry cloth HUCK BLUE (1) Single drape 41" X 58" SMS (1) MAYO tray large (1) table cover reinforcement 50" X 90" (1) drape incision antibacterial agent 23" X 17" (1) drape slimming (1) surgical blade #10 Stainless steel (1) Cup lid specimen (with 1 piece) blade scalpel #15 Stainless steel (30) Knee sponge prewash 18" X 18" XRD (1) Strip STERI closed WX 4" (1) Polisher cauterization tip ( 1) Needle ECLIPSE 22 X 1 Y2 (4) ABS harness 20 inches (1) Syringe 20cc without needle Luer lock (2) LITE gloves (1) Skin marking ink with 8 labels/timeout/ruler (1) Counter NDLE /Blade 60C foam/STR/MAG/STR (1) Force TRIVERSE(1) Syringe bulb 60CC (1) Blade lengthened ELECT. 16.51cm(2) Tube suction connection Y.” X 12' (2) CHLORAPREP 26ML applicator blue Green (1) table cover BTC 77" X 110" HD full coverage product use: EO sterilization operation convenient packaging, packed in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – C – BIRTH PACK II {2) CUSTOMEDCONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4) TOWEL ABSORBENT 15"" X 20"" LIF(2) GOWN XLGE SMS IMPERVIOUS REINFORCED LIF (1) Cover MAYO stent reinforcement LIF (1) BABY BABY 30"" X 30"" POLYABS IMPERVIOUS LIF (1) Syringe ear/ulcer 2oz LIF(2) Pad obstetric X large (1) Bowl belt/ Lid ounces plastic (80) clip umbilical cord LIF(1) bag suture flower LIF(1) hanging caesarean section bag 102"" X 121"" X 78"" LIF (1) table reinforcement 50"" X 90"" LIF product use : EO sterile surgical kit, packaged in a polyester/polyethylene breathable bag with Tyvek dual vents.” Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-OPHTALMIC PACK- (3) Absorbent towel 15" X 20" LIF (1) MAYO support cover reinforced LIF (1) Eye mask with bag LIF (2) Syringe 3cc needleless LUER lock LIF (10) COTICATON TIPICATON "Wood (1) Syringe 10cc without needle LUER lock LIF (2) Needle 18G X 1 Y." (1) Needle 25G X 5/8" (2) Eye pad 2 1/8 X 2 5 /8 UF (5) EYE SPEAR Micro Sponge (2) LITE Glove Life (1) Bipolar Cable (1) Universal Eye Mask (1) Eye Mask Bipolar (1) IV ADM. Set 15 drops 106 inches long L/F(1 ) Table cover reinforcement 50" X 90" UF(1) Minimum knife/blade. Rounded edges (1) Knife 15 5.0 Controlled (1) Plastic tray 3/compartment (1) Knife 3.2 mm bevel (1) CYSTOTOMO IRRIG .25GA X5/8(1) MAYO TRAY LARGE(2) GOWN STANDARD LARGE SMS STD VELCRO NECK(1) PVP PAINT 8" STICK SPONGE(1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LFEO Sterile operation convenient packaging, packaging Polyester/polyethylene breathing bag with Tyvek dual vent Customed has been determined, and the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Urology bag; 900-2510; Package contains: (2) Towel absorbent 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF( 10) Gauze sponge 4" X 4" 12PL Y (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) TUY set 81 inches 2.1M ordinary clams (1) GOWN SURG reinforced LGE towel and wrap (1) Tubular suction connector 1 /4 X 12' UF (3) 10cc gel syringe pre-filled(1) RC table cover X44FIN 78(1) SYRINGE 60ML LUER LOCK W/O NDL UF The ventilated bag has Tyvek dual exhaust ports. The customer has determined that different catalog numbers may affect package integrity (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed – OR TOWELS- CUSTOMED-(6) TOWELS CLOTH HUCK BLUE(I) WRAPPER 20" X 20EO sterile surgical convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek Double vents. Customed has determined that there is a possibility that the integrity of the package may be compromised due to different catalog numbers (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized Inc-Laparoscopy Obstetrics and Gynecology Package-(1) DURAPREP Surgical Solution 26 ml LIF (1) Piece T Laparoscopy SMS LIF (2) Draping Utility with Tape LIF (1) Suspended piece 41" X 58" SMS ABS LIF(5) Scarf 1B" x 20" LIF(1) PVP Triple swab iodophor(1) Pendant laser camera W/EL 6" X 96"(1) Tube suction connection . %" X 12' LIF(2) Needle and blade counter 10C MAG/CLEAR LIF(1) Surgical blade #11 Carbon steel(1) Table cover 44" X 78" Reinforced LIF(1) TEGADERM Transverse dressing 6" X 8"(2) Tights with 7" cuffs 30" X 42"(10) Gauze Sponges 4" X 4" 12PLY XRD(1) Bag type urinary tube 2000ML Anti-reflux(1) Tracheal inflator W/0 ring Adapter LIF(1) TUR CySTO flushing device 79"(1) FOLEY FRHETER 5CCWA2Y16;) Syringe 10CC without needle LUER LOCK LIF(2) GOWN IMPERVIOUS EXTRA REINF XLG LIF(1) TROCAR Endo.XCEL Expansion tip 5MM (K5LT)( 1) PNEUMO INSUFLAT needle 150MM LUER LOCK FA LIF 150MM LUER LOCK FA LIF green label (1) AZUL DE METILENO label (1) heparin white label (1) lidocaine yellow label ilized surgical convenience package, packaged with Tyvek double ventilation In the polyester/polyethylene breathable bag of the mouth. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – KNEE ARTHROSCOPY PACKCONTENTS: (1) TOWEL ABSORBENT 15"" X 20"" L/F (10) GAUZE SPONGE 4"" X 4"" 16PLY(1) SAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) Needle injection 18G X 1Y:z(1) U-DRAPE 60"" X 70"" with bifurcation (1) Skin marking ink W/8 label (2) Tube suction connection .WX 12' LIF (1) CAST filled soft roll 6 X 4yds L/F(2) Bandage elasticity 6"" X 5yds L/F (4) Strip 24"" X 4"" LIF(1) Pk. STERI Strip closure Y:z"" X 4 "" LIF (1) Sheet arthroscopy ""T"" STD SMSW/bag L/F (5) Knee sponge prewash 18"" X 18"" XRD LIF ( 1) Needle spinal anesthesia 18G X 3% LIF (1) Syringe 10cc W/0 NDL L/LOCK LIF (1) Pendant video camera 13cm X 244cm LIF (1) Robe IMPERV. XTRA REINF. LGE TIWRAP (1) MAYO bracket cover Reinforced LIF(2) Needle 25 X LIF (1Y: 1) Overtime lighthouse non-woven fabric ST. LIF(1) STOCKINETTE IMPERV. 14"" X 48"" LIF (1) Table cover REINF. 50"" X 90"" LIF (1) Scalpel Weighted Safety #11(1) Safety Gliding Needle 21G X 1%(1) Surgical gown. Ryan. XL EXTRA LONG LEVEL IV Product use: EO sterilized surgery convenient packaging, packaged with Tyvek double Vents in polyester/polyethylene breathable bags.” The customer has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to the patient due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Small Laparotomy Surgery Kit-(1) Surgical drape T Laparotomy (1) Pouch suture LIF (4) Surgical drape utility tool with tape LIF (1) Table cover reinforcement 50" X 90" LIF(1) MAYO Bracket cover reinforcement LIF() Absorbent towel 15" X 20" LIF(2) Water-impermeable oversized robe(1) Drape% ECONOMY 53" X 77" LIF(1) Burning pencil rocker switch (1) Practical bowl and 2 16 COUNTER 1 OC MAG/CLEAREO with needles, convenient packaging for sterile surgery, packed in a polyester/polyethylene breathable bag with Tyvek double vents. Customized has been determined, different catalog numbers (multiple batches) Times) packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc – Laparoscopy Obstetrics and Gynecology Package – (1) Enhanced 44" X 78"(1) Laparoscopy film "T" SMS(3) Absorbent towel 15" X 20"( 1) Surgical blade #11 stainless steel (1) Reinforced bracket cover (1) Syringe 10cc without needle LUER lock (2) Leggings with 7" cuffs 30" x 42" (1) With pouch 44" X 35 "(4) Draped utility belt GOW compression belt (2) V LARGE SMS(1) CONNECTING TUBING 3/16" X 12" EO sterile surgical convenient packaging, packaged in polyester/polyethylene breathable bag with Tyvek Double vents. Customed has determined that different catalog numbers may affect package integrity (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customized-Orthopedic packaging basic code 900-2830. Content: (3) Towel absorbent 15"" X 20"" (1) Cover MAYO bracket reinforcement (1) U-DRAPE 60" "X 70"" with tape to split 6 X 21 splits (1) drape% ECONOMY 53"" X 77"" (4) tape with drape utility (1) bag stitch flowers (1) slice split /Adhesive 108"" X 77"" STD SMS (1) Reinforced cover table 50"" X 90"" (1) STOCKINETTE IMPERVIOUS 14"" X 48"" (1) Timeout beacon non-woven fabric (1) Robe XL SMS IMPERVIOUS Enhanced AAMI Class Ill (1) Polished soldering iron tip markings (1) Illin Skin with 8 labels/timeout/ruler (1) Counter NDLIBLADE 20C foam/MAG(1) Pencil burning rocker with holster Switch (1) Extra reinforcement LGE T/wrapped for impermeable robe AAMI LEVEL Il (1) Plastic bag (1) ELECTRODE DUAL DEPRES Product use: EO sterilization surgery convenient bag, packaged in polyester/ with Tyvek double vents Polyethylene vented bags.” Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc" Customized-ACDFPACKSURGICAL Center; Code 900-2917. Content: (1) Solution DURAPREP 6ML LIF(4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF(3) GOWN SOFT SMS STD XL SET IN SLEEVE) Towel ABSORBEN 15"" X 20"" UF(1) Reinforced table cover 50"" X 90"" L/F (1) MAYO Stand cover reinforcement LIF(2) Overhang o/.. 60" "X 76""Enhanced LIF (1) Overhanging Thyroid 100"" X 142"" X 72"" LIF(1) FLUORO COVER 30"" X 30"" W/RUBBAND ​​L/F (1) DRAPE INCISE IOBAN 13" "X 13"" (2) LITE GLOVE LIF(2) Pipe suction tube connector. WX 12' LIF (12) Terry cloth HUCK BLUE LIF(1) Practical bowl 16oz LIF(10) Gauze sponge 4"" X 4"" 16PLY XRD LIF(5) LAP Sponge Pre-wash 18"" X 18"" XRD LIF(1) Skin marking W/RULER LIF(9) Skin marking label 1.25 XY:!(1) RULER(1) Needle and blade counter 20C foam /MAG LIF(2) Syringe 20cc W/0 NDL LUER LOCK LIF (2) Syringe 3cc W/0 NDL LUER LOCK LIF (1) Bulb syringe 60cc LIF(3) Needle 18G X 1Y:! LIF (1) X Needle 30G ISP /F(1) Needle Spinal Anesthesia 18G X 3W' LIF (2) Blade Surgery ICAL# 15 Carbon Steel(1) Timeout Beacon Non-woven LIF(2) Tape TEGADERM 2 3/8 ""X 2 o/. .""L/F(2) medicine cup 2 ounce LIF Product use: EO sterile surgical convenience package is packaged in a polyester/polyethylene breathable bag with Tyvek double vents." Customed has been determined, different catalog numbers ( Multiple batches) packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc "Customed – ORTHOPEDIC SURGICAL PACKHOSPITAL SAN CRISTOBALCONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL(1) TUBE SUCTION CONNECT W'X 1 2'LIF(1) BAG GLASSINE (2) LITE GLOVE(1) Table cover BTC 77"" X 11 0"" HD full coverage LIF(1) MAYO support cover reinforced LIF (5) Towel absorbent 1 5"" X 20"" LIF(4) Overhang Utility and tape LIF (1) Overhanging piece 70"" X 100"" L/F(5) LAP Sponge PREWASH 18"" X 1 8"" XRD LIF (1) MAYOTRAYLARGE(1) Overhang top with adhesive 108"" X 50"" STD SMS LIF (1) Skin stapler width 35 LIF (1) Overhang incision anti-MI CROBIAL 23"" X 1 7"" LIF (1) Skin marker with ruler (1) U-shaped overhang 60 "" X 70"" with tape dividing 6"" X 2 1 "" LIF (1) Abdomen pad 8"" X 7""h."(1) YAUNKAUER straw, no exhaust LIF(1) SOLUTI ON SURG ICAL DURAPREP 26ML LIF (1) Blade SURG ICAL #10 stainless steel (I) Split piece with adhesive 108"" X 77"" STD SMS LIF (2) *Prs. GLOVE # 8.5 SURGEON NEUTRALON LATEX(I) *Pr . GLOVE#8 SURGEON NEUTRALON LATEX(I) GO WN SURG. Enhanced XL towel/wrap AAMI Ill (3) Robe XL SMS IM Permeability enhanced AAM I III LIF (I) Burning pencil rocker switch (2) *Prs. Glove surgery. # 8 Powder (4) Prs. Glove surgery. 8.5 Product use: Convenient packaging for EO sterilization surgery, packaged in a polyester/polyethylene vented bag with Tyvek double vents. "The customer has determined that different catalog numbers (multiple batches) may affect packaging integrity. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc" Customized-Shoulder Arthroscopy Package Content: (1) Suture bag flower (1) Practical bowl 32 ounces. (2) Overhang piece 70"" X 100"" (1) Surgical enhancement Type XLGE T/Wrap(1) Needle. 18G X 3ST.(1) STOCKINETTE 6 X 48""(1) Syringe 20cc without needle Luer lock(1) SCALPEL Weighing Safety# 11(1) Bulb Syringe 60cc( 1) Hanging beach chair 10 Crossbody bag pre-washed 18"" X 18"" XRD(2) U-DRAPE 60"" X 70"" with bifurcation (2) Hanging piece 41"" X 58"" SMS(1) STOCKINETTE IMPERVIOUS 14"" X 48"" (1) Table cover reinforcement 50"" X 90"" (1) COBAN WRAP TAN 4"" X 5yds(1) Timeout beacon non-woven fabric (2) Surgical gown. Enhanced type XL Super Long Level Four(2) MAYO Bracket Cover REINFORCED(1) SKIN MARKER Ink with 8 LABEL(1) TUBE CONNECTING SUCTION X"" X 12' (1) MAYO TRAY SMALL(1) CAMERA COVER W/ELAST.Product Usage :EO sterilized surgical convenience package packaged in a polyester/polyethylene breathable bag with Tyvek double vents.” Customed has determined that the integrity of packaging for different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc" Customized-Surgical package contents: (1) Suture bag flower (1) Package 30"" X 30"" (2) Practical bowl 16 ounces (1) Tray organizer full depth (1) ) Specimen container 4 ounces (with lid and label) 1) YANKAUER straw without vent (5) Knee sponge prewash 18"" X 18"" XRD (1) Blade surface treatment. #15 carbon steel (2) ) Needle and blade counter 1Oc MAG/transparent (1) Burning tip) BLADE SURG. #10 Carbon steel (2) Light gloves (10) Gauze sponge 4"" X 4"" 16PLY XRD (1) Burning pencil rocker switch (1) Time-out beacon non-woven STProduct Purpose: EO disinfection surgery convenient bag is packaged in a polyester/polyethylene breathable bag with Tyvek double vents.” Customed has been confirmed, different catalog numbers (multiple batches) Packaging integrity may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Caesarean surgery kit; 900-2516; Package includes: (I) table cover 44" X 90" (I) cauterizing pencil push bottom (4) towel absorbent 15" X 20" L/F (I) Bulb Syringe 60cc LIF(4) Dangling practical WIT APE LIF (I) Skin marking with ruler (I) Suture bag flower LIF (I) Y ANKAUER Suction tube with 0 exhaust LIF (2) Counter NDL/blade IOc MAG/transparent (I) dress XL SMS IMPERV. Enhanced LIF (5) Knee sponge pre-wash 18" X 18" XRD LIF (I) surgical gown enhancement. LGE T/WRAP LIF(I) TUBE SUCTION CONNECT W'X 12' LIF (2) LITE GLOVE LIF(10) GAUZE SPONGE4" X 4" 16PLY XRD LIF (2) Overhanging piece 41" X 58" SMS LIF(I) CAUTERY TIP POLISHER LIF (I) MERLING skin preparation application. 39ML LIF(I) Practical Bowl Pint 16oz LIF (I) Skin Staple Food 35 Wide Life (I) Practical Bowl Quarter 32oz LIF(I) Blade SURGICAL II Carbon Steel (I) Tray MAYO Small (I) Blade 20 Steel) MAYO STAND COVER REINFORCED LIF (I) DRAPE LAPAROTOMY 100" X 72" X 124" W/POUCH Product use: EO sterilization operation convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents The customer has determined that it is possible that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Femoral Angiography Package-(1) Table cover reinforced 50" X 90" UF (1) Robe large SMS IMPERVIOUS reinforced LIF (1) Towel absorbent 15" X 20" UF (1) DRAPE ANGlO" X 90" UF(1) 4) Towel Buhak (blue) UF(3) Syringe 1 Occ Needle-free Luer lock UF(1) IV ADM set 15ML 1 06" long life (20 ) Gauze sponge 4" X 4" 12PL Y LIF(1) Syringe 18G X 1Y:. ST. UF(1) Needle subcutaneous injection 21G X 1Y:. ST. LIF(2) Medicine cup 2oz. CLEAR LIF(1) SCALPEL Weighted Safety #11(2) GLORASCRUB SWABSTICK 5.1 ML LIF(1) SURG Enhanced Large Towel/Package Life Cycle(1) Specimen Container 4 oz. Life Cycle with Lid and Label(1) Needle 25G X 5/8 ST. Life Cycle (1) Syringe 3cc Needleless LUER Locked Life Cycle (1) TC. Tip LIF(1) Practical Bowl 32oz LIF(1) Practical Bowl 16oz L/F(1) FORCEP KELLY STRAIGHT 5.5" LIF(1) MOSQUITO HALSTED CVD 5" LIF(1) Tray organizer 1 SCEP LIF MAYO 6.75 STRAIGHT LIF(1) Stent needle WEBSTER 4.75 LIF(1) Guide wire .035" X 150cm UF(1) Timeout beacon non-woven ST. UF(1) MAYO tray small LIF(2) Towel clip UF(2) Wrapped with blanket and tape LIF(1) Pr. Glove surgery. #7Y:. DERMA PRENE P/F LIF(2) Syringe 20cc without needle LUER lock LIFLABEL sample(1) Needle and blade counter 60C Foam strip/MAG strip LIF(1) Needle 18G X 2 o/.MARKI AMC/4 (1) INK WITH/8 LABELEO sterile surgical convenience bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-0.B. Packaging--(1) Table cover 44" x 90" (1) Hip sagging, with pouch (2) Tights with 7" cuffs 30" x 42 "(1) Long gown impermeable and reinforced SMS(3) Absorbent towel 15" x 20"(1) Obstetrics X large pad(1) Vaginal sponge XRD(10) Gauze sponge 4" X 4" 12PLY XRD(1) Umbilical cord Clip(1) Baby blanket printing(2) Ear/ulcer syringe 2oz(1) SET UP COVER CLEAR POLY(1) BASIN WASH 7QT.(1) ABDOMINAL DRAPE WITH TAPE LIF(2) KELLY FORCEP STRAIGHT 5 %(1) MAYO SCISOR STRAIGHT 6%(1) BABY BEANNIESEO sterile surgical polyester/polyethylene packaging breathing bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Shoulder Bag-Customized-(1) Table cover reinforcement 50" x 90" LIF(2) MAYO bracket cover reinforcement L/F(1) U-shaped suspension 60" X 70" strap Tape bifurcation (4) Towel absorbent 15" X 20" LIF(4) Draping utility with tape LIF(2) The robe is impervious to water and super strong reinforcement (1) Sheet drape 70" X 100" SMS LIF(1) ) Cup sample, 4 oz (1) tube suction connector with lid. Y." X 12' LIF(1) Skin marker with ruler(1) Syringe 60ML without needle LUER lock LIF(1) Bag suture flower LIF(1) Syringe 20cc without needle LUER lock LIF(1) Needle 1% XG LIF(1) Blade Surgery #11 Carbon Steel (1) Blade Surgery #15 Carbon Steel (1) Needle and Blade Counter 60C Foam Strip/Magnetic Strip LIF(1) Needle Spinal Anesthesia. 18G X1OC 3% STEP 14" X 48 "LIF(1) Dangling beach chair shoulder joint. (1) Surgical gown. Reinforced X large towel/wrapping (2) Gauze sponge 4" X 4" 16PL Y XRD L/F Product use: EO disinfection operation is convenient to pack into poly Ester/polyethylene vented bag with Tyvek double vent packaging.Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may result in product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Laparoscopy Kit;; Code 900-3178; Contains: (1) bulb syringe 60cc LIF(10) gauze sponge 4" X 4" 16PLY XRD LIF(1) MAYO bracket cover Reinforced LIF(1) Table cover reinforcement 50" X 90" LIF(3) GOWN SURG EXXINFO Long Class IV(4) Towel absorbent 15" X 20" LIF(1) Pendant camera 13cm X 244cm LIF(3) LITE glove L ​​IF(1) Suspended knee and abdomen belt bag 102" X 122" X 78" surgical blade # 11(1) Syringe 10cc without needle LUER lock LIF(4) Cover cloth utility with tape LIF(1) Suture bag Flower L/F(1) Needle and Blade Counter 10c MAG/Transparent LIF(1) FRABLE LIF(10MM) Male MONOP. LIF(1) Sample container 4 ounces, with lid and label (2) Piece% 60" X 77" Suspended reinforced LIF(1) tube inflation kit with 0 ring adapter LIF(1) package 24" X 24" LIF (1) ULTRA VERES needle 120 mm LIF(1) TROCAR Endo.XCELL expansion tip 11 MM(1) TROCAR EndO .XCELL Expansion Tip 5MM LIF(1) Cannula 5MM XCEL Cannula LIF(2) Denture Cup (82 oz W) Dressing Non-ADH TELFA 4" X 3"(1) CHLORAPREP 26ML Applicator TEAL LIF Product Use: EO sterilization Surgery convenient packaging is placed in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may be due to product contamination Or lose sterility and cause harm to the patient.

Customized on August 29, 2014; Customized by Inc-General Small Package-(1) MAYO Support Cover Reinforced LIF (2) Bowl Utility 16 oz LIF (1) Tip Burning Polisher LIF (3) Towel Absorbent 15" X 20 "LIF(1) Bowl utility tool 32oz(1) B stitching flower(1) YANKAUER straw without exhaust LIF(10) Gauze sponge 4" X 4" 16PLY XRD LIF(1) Table cover reinforcement 50" X 90" LIF(2) Robe impermeable reinforcement LARGEAU rocker switch LIF(1) Blade surgery #10 Stainless steel(1) Pipe suction connector~" X 12' LIF(5) Knee sponge prewash 18" X 18" XRD LIF (2) LITE gloves L​​IF(1) Cloth curtain POUCH 102" X 121" X 78" STD SMS(4) Covering utility tool with tape LIF(1) 4oz container specimen with lid and label(1) Surgical blade #15 Carbon steel (2) Cover cloth 41" X 69" (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIFEO sterile surgical convenient bag, packaged in a polyester/polyethylene breathable bag with Tyvek double vents . Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customed-Cirugia Cardiovascular Case Cart; Code 900-1415A; Contains: (1) CIRUGIA CARDIOVASCULAR .(INDUCCION)(1) CIRUGIA CARDIOVASCULAR (CIRUGIA)(1) CIRUGIA CARDIOVASCULAR (PREP ENFERMERACIRCULANTE) )(1) CIRUGIA CARDIOVASCULAR (PERFUSION)(PERFUSION)(CIRUGIA)(CIRUGIA)(CIRUGIA)(CIRUGIA)(CIRUGIA) OPEN HEART TRAY Product use: EO sterilization surgery convenient bag, packaged in a polymer with Tyvek double vents In an ester/polyethylene breathable bag. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Laparoscopic Colorectal Surgery Package Code 900-2259A; Contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF(4) DRAPE UTILITY WITH TAPE LIF(3) TOWELS ABSORBENT 15" X 20" LIF(2) LEGGINS W/7" Cuff 30" X 42" LIF(1) Scalpel# 15 Stainless Steel(1) Scalpel# 11 Stainless Steel(1) Robe IMPERV. Additional reinforcement. XLG AAMI Il l LIF(1) Rinse straw double nail LIF(1 0) gauze sponge 4" X 4" 16PL Y XRD LIF(2) practical bowl 16 ounces. LIF(2) PK. STERI strip closure %" X 4" L/F(1) ACTIFOG Solution with foam pad LIF(1) Table cover reinforcement 50" X 90" LIF(1) MAYO Support cover reinforcement LIF(1) Needle ULTRA VERES 120MM LIF) STAPLE ARTICULATING ECHEL 60MM LIF(1) RELOAD WHITE 60MM ECHELON L/F (2) CANNULA 5MM XCEL Sleeves LIF (1) TROCAR 5MM blade barbed sleeve UF(1) TROCAR EE 12MM blade L/F (2) Sleeve 5MM blade L/F knee sponge prewash 18 inches X 18 inches XRD LIF (1) Tracheal inflation bag set with 0 ring adapter LIF (2) LITE gloves (1) Pencil type cauterizing rocker switch with leather cover LIF (1) Electrode double DEPRES (1) Laparoscope with transparent instrument bag (1) Counter NDLE/Blade 20C Foam/MAG LIF(1) Skin Marking Ink Band 8 Labels/Timeout/Ruler LIF(1) Bag Stitch Flower(1) Robe IMPERV Extra Reinforcement and Large Mop 1) POLISHER CAUTERY TIP LIF(1) BAG GLASSINE(1) RELOAD BLUE 60MM LIF(1) TIME OUT BEACON NON WOVEN LIF Product use: EO sterilization operation convenient packaging, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Product use: EO Sterilized surgical convenience package, packaged in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has been determined, and the package integrity of different catalog numbers (multiple batches) may be affected. To influence. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Advanced OB Bag-Customized-(1) Table cover reinforcement 50" X 90" LIF(10) Gauze sponge 4" X 4" 12PLY LIF(2) Tight fit with 7" cuffs Pants 30" x 42" LIF(2) PAD OBSTETRICAL X-LARGE ST.(2) Sheet cover 42" X 55" LIF(1) Hip cover with pocket cover (1) Abdomen cover with 40" X 54" belt Tape LIF(1) Robe X-Large SMS IMRCVEDIOUS (1) Bowl plastic 80 ounces with lid(1) Ear ulcer syringe 2 ounces LIF(1) Umbilical cord clip LIF(1) Baby blanket imports 30" X 30" polymer ABS .LIF(1) Towel absorbency 15" X20 (1) LAP SPONGE PRE-WASH 18" X 18" XRD LIFEO Sterile surgical convenient packaging, packed in a polyester/polyethylene breathable bag with Tyvek dual vents . The customer has determined that different catalog numbers may affect packaging integrity (multiple batches). This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Customized by Inc-Nerve Spine Pack-(1) Bag suture flower (1) Cover table 44" X 90" (4) Absorbent towel 15" X 20" UF (1) Laparotomy T sheet 102" X 78" X 121" STD SMS (4) Drape utility with tape LIF (3) Robe IMP. EXTRA enhanced large TIWRAP (1) DURAPREP surgical solution 26 ml UF (1) Incision drape 23" x 17"(1) Instrument bag (2) POLISERY LIF) Cautery pencil manual switch life (2) Container specimen 4 ounces with lid and label (1) YANKAUER straw. Tube without exhaust tube (2) LITE gloves L​​IF (1) Pipe suction tube connector. Y.." X 12' SKIN (1) Mark with ruler (1) Incision drape antibacterial 23"x17" LIF (1) Pk surgical strip W'X 6"(5) Knee sponge Pre-washed 18" X 18" XRD L/F (20) gauze sponge 4" X 4 inches 16 layers XRD LIF(1) Scalpel with handle #10 stainless steel (5) overhang% ECONOMY 53" X 77" LIF(2 ) Table cover HD 77" X 110" L!F (1) MAYO tray large (1)) Utility bowl 16 oz LIF (2) Needle and blade counter 10c MAG/transparent L/F(2) Syringe 10cc without needle LIL UF (1) Scalpel with handle #15 stainless steel (1)) J VAC RESERVOIR 300 mLEO Sterile surgical convenient packaging, packed in a polyester/polyethylene breathable bag with Tyvek double vents. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterility.

Customized on August 29, 2014; Inc Customized-Pediatric Knee Packaging-(I) Small knee 102" X 121" X 78" (I) MAYO bracket cover reinforcement LIF (I) table cover reinforcement 50" X 90" LIF (2) Suspended piece 41" X 58 "SMS(2) TOWELS ABSORBENT 15" x 20" LIF(I) BAG SUTURE FLORAL LIF(4) DRAPE UTILITY WITH TAPE L/FEO sterile surgical convenient bag, packaged in polyester/poly Vinyl breathable bag with Tyvek double vents. Customed has determined that the integrity of the packaging of different catalog numbers (multiple batches) may be affected. This may cause harm to patients due to product contamination or loss of sterile conditions. 2014 Customized on August 29; Customized by the company-Small abdominal surgery packaging-(1) Table cover 50" X 90" reinforced LIF (1) GOWN SURG. X Large reinforced towel/wrap (1) Top X-Large SMS Permeation-enhanced LIF(3) Towel 15" X 20" LIF 1) YANKAUER straw without exhaust port (2) Counter needle and blade 10C MAG/transparent LIF(5) LAP Sponge PreWash XRD L/F(4) DRAPE With tape LIF(2) LITES GLOVE LIF(1) pipe suction connection utility. ~" X 12 feet LIF(1) Lid Mayo bracket reinforcement LIF(1) Utility bowl 32oz(2) Utility bowl 16oz(1) with Specimen container with lid and label 4oz(1) Burning tip polisher LIF(1) #10 SU carbon steel(10) Gauze sponge 4" X 4" 16-layer XRD LIF(1) Pouch suture flower(1) In drape piece Size 41" X 69" LIF(1) Suspended knee with a small bag SMS STD L/FEO sterile surgical bag placed in a polyester/polyethylene breathing bag with Tyvek dual exhaust ports. Customed has determined that the packaging integrity of different catalog numbers (multiple batches) may be affected. This may result in product contamination or loss of sterility.

Release date, recalled manufacturer, product name/product, reason for recall

August 1, 2014 Carestream Health Inc. Kodak DirectView DR 9000 system-Kodak DirectView DR 9000 system; catalog numbers 1966688 (U.S. and Canada) and 8161937 (outside the U.S. and Canada)-permanently installed diagnostic X-ray systems, consisting of 3 The main components are: operator console; U-arm assembly with X-ray tube, including collimator; and fixed generator. Carestream has discovered a control system failure involving the Kodak Directview DR 9000 system. When radiographers use the "up" or "down" control buttons to locate the device, the failure may cause the DR 9000 U-arm to move down unexpectedly. This downward movement speed is three times the normal speed and will continue until the device control button is released; this

On August 1, 2014, Ortho-Clinical Diagnostics VITROS 4600 chemical system – VITROS 4600 chemical system (VITROS 5; 1 FS system family member) — VITROS 4600 chemical system is designed to be used for in vitro quantitative measurement of various analytes for clinical interest; Use VITROS Chemistry Products Slides (colorimetric endpoint; rate; ion selective electrode; and immunorate method) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods). The VITROS software is part of the VITROS 3600; 4600; and 5600 systems. VITROS 3600; 4600; & 5600 systems share the same software foundation. VITROS sample programming includes sample identification (SID); test request; and patient demographic data. Patient demographics include patient name; address; date of birth; gender; physician; and patient identification (PID). Ortho Clinical Diagnostics found an abnormality in the VITROS system software version 3.0 and below. Internal testing confirmed that under very specific conditions; incorrect patient demographic data is associated with the sample identification (ID) number.

On August 1, 2014, Ortho-Clinical Diagnostics VITROS 3600 immunodiagnostic system-VITROS 3600 immunodiagnostic system-used for in vitro quantification; semi-quantitative and qualitative measurement of various analytes of clinical interest; using VITROS immunodiagnostic product reagents. The VITROS software is part of the VITROS 3600; 4600; and 5600 systems. VITROS 3600; 4600; & 5600 systems share the same software foundation. VITROS sample programming includes sample identification (SID); test request; and patient demographic data. Patient demographics include patient name; address; date of birth; gender; physician; and patient identification (PID). Ortho Clinical Diagnostics found an abnormality in the VITROS system software version 3.0 and below. Internal testing confirmed that under very specific conditions; incorrect patient demographic data is associated with the sample identification (ID) number.

August 1, 2014 Ortho-Clinical Diagnostics VITROS 5600 integrated system-VITROS 5600 integrated system-for in vitro quantification; semi-quantitative; qualitative measurement of various clinically interesting analytes; use of VITROS chemical product slides; VITROS chemistry Products MicroTip reagents and VITROS immunodiagnostic product reagents. The VITROS software is part of the VITROS 3600; 4600; and 5600 systems. VITROS 3600; 4600; & 5600 systems share the same software foundation. VITROS sample programming includes sample identification (SID); test request; and patient demographic data. Patient demographics include patient name; address; date of birth; gender; physician; and patient identification (PID). Ortho Clinical Diagnostics found an abnormality in the VITROS system software version 3.0 and below. Internal testing confirmed that under very specific conditions; incorrect patient demographic data is associated with the sample identification (ID) number.

August 1, 2014 Advandx Inc AdvanDx BC Fast FISH Fixation Kit (Blood Culture) – AdvanDx BC Fast FISH Fixation Kit (Blood Culture); 50 tests. The QuickFISH Fixation Kit is a separately sold component for the QuickFISH BC test for Staphylococci. Catalog number: QFFixBC1-50 (a component of QFSTABC1-50) A positive result is obtained in the internal negative control well for the QuickFISH BC test for Staphylococcus; quality Control failure

August 1, 2014 X Spine Systems Inc Serrated Soft Tissue Shield – Serrated soft tissue shield is a surgical instrument packaged as part of the Silex Sacroiliac Fusion System. The soft tissue shield is a surgical instrument guide in the Silex sacroiliac joint fusion system, designed for sacroiliac joint fusion, including sacroiliac joint rupture and degenerative sacroiliac arthritis. Revision B of the device organization shield is 7 mm longer than the previous design.

August 2, 2014 Zimmer; Inc. Tapered-Screw Vent Implant – Tapered-Screw Vent Implant; Ha; 4.7 mm deep x 8 mm long x 4.5 mm; part number TSVWH8 Zimmer Dental is recalling tapered spiral vented implants, Because the state of the inner bottle is "03.7 x 8mm" instead of "04.7 x 8 mm".

August 4, 2014 Brainlab AG Brainlab ExacTrac – ExacTrac is designed to be used to place patients at precisely defined points within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures; for the treatment of lesions; when radiotherapy is required, Tumors and diseases in any part of the body. ExacTrac can also be used to monitor the patient's position during treatment. In ExacTrac v.6.0.4 there are anomalies detected inside Brainlab; when multiple isocenters (radiotherapy targets) are used in a single plan under unusual workflow conditions. When multiple isocenters (multiple radiotherapy targets) are used in a plan; for specific abnormal workflows that involve switching back to the isocenter; X-ray or cone beam CT positioning

August 5, 2014 Boston Scientific CRM Company ENDOTAK RELIANCE SG-Boston Scientific ENDOTAK RELIANCE SG; transvenous defibrillation lead; type 0180 and 0292; sterile EO. Product use: The ENDOTAK RELIANCE lead provides pacing and rate sensing, and provides cardioversion and defibrillation shocks for the automatic implantable cardioverter defibrillator (AICD) system. After reviewing the manufacturing test records of the Boston Scientific ENDOTAK RELIANCE implanted lead wire, it was found that the suspicious test data was recorded incorrectly. Specifically; some test results are recorded as "failed" and there are no other signs of failure. There are no reports of injuries caused by these devices.

August 6, 2014 PerkinElmer Health Sciences; Company Panthera-Puncher 9. – Panthera-Puncher 9. Panthera-Puncher 9 is a sample transfer instrument for professional use. Sample; a dried blood plate; extract from a larger area sample (dried blood spot) by flushing a disc of the specified size into the sample collection container; for example, a 96-well microtiter plate. The identification information of the sample punched into a specific hole of the plate is stored and continues to the next instrument, or the data is transferred to the LIMS. Samples prepared with Panthera-Puncher 9 are at risk of incorrect results

August 6, 2014 Coltene Whaledent Inc Ultimate Dams-Latex Dental Dams Coltne/Whaledent Inc., labeled Non-Latex Dental Dams, received a complaint about incorrect dental dam color. During the internal investigation; the company discovered that the latex dental dam has been used in non-latex packaging.

August 6, 2014 BioMerieux SA VIDAS Total Prostate Specific Antigen – VIDAS TPSA is designed to be used as an automatic quantitative measurement of the level of prostate specific antigen in human serum or plasma. The product is not approved or authorized for distribution in the United States.

August 7, 2014 PerkinElmer Health Sciences; Inc. PerkinElmer Specimen Gate Screening Center software-PerkinElmer Specimen Gate Screening Center software; Version 1.4 and 1.6; Product number: 5002-0500 Specimen Gate Screening Center for storage The data processing module in; retrieval; and processing laboratory data. Demographic information and test results may not match.

Aug-07-2014 ICU medical; Inc. Transpac Trifurcated monitoring kit with Safeset Reservoir-single-line Transpac IV monitoring kit with 03 ml squeeze flushing device; CSP and blue stripe tube; catalog number 011-46108-38 Transpac Trifurcated monitoring kit, With Safeset Reservoir; squeeze flushing and sampling port. The monitoring kit is used to measure and monitor fluid pressure; rehydration; and blood draw. The ICU is aware of a component problem where the connection on the arterial monitoring kit may break and cause fluid leakage.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated Monitoring Kit and Safeset Reservoir – Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices; No Needle Valve and Macrodrip; Catalog No. 011-46104-33 Transpac Trifurcated Monitoring Kit with Safety Reservoir; Squeeze the flushing and sampling ports. The monitoring kit is used to measure and monitor fluid pressure; rehydration; and blood draw. The ICU is aware of a component problem where the connection on the arterial monitoring kit may break and cause fluid leakage.

Stryker Instruments Div on August 7, 2014. Sonopet Ultrasonic Suction Console of Stryker Corporation-Sonopet Ultrasonic Surgery System Console; Ultrasonic Suction Device; Stryker Medical Technology. The company received complaints about insufficient irrigation at the tip of the Sonopet system. Lack of irrigation may cause the tip to overheat.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated Monitoring Kit with Safeset Reservoir-Single Transpac IT Monitoring Kit with 03 ml Flushing Device; No Needle Valve; Large Drops; Catalog No. 011-46106-29 Transpac Trifurcated Monitoring Kit with Safeset Reservoir; squeeze flushing and sampling port. The monitoring kit is used to measure and monitor fluid pressure; rehydration; and blood draw. The ICU is aware of a component problem where the connection on the arterial monitoring kit may break and cause fluid leakage.

Aug-07-2014 ICU medical; Inc. Transpac Trifurcated monitoring kit with Safeset Reservoir – Transpac IT w/10 cc Safeset Reservoir; 03 ml flushing device; 2 CSP and red stripe tube; catalog number 011-46112-21Transpac Trifurcated monitoring kit, With Safeset Reservoir; squeeze flushing and sampling port. The monitoring kit is used to measure and monitor fluid pressure; rehydration; and blood draw. The ICU is aware of a component problem where the connection on the arterial monitoring kit may break and cause fluid leakage.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated Monitoring Kit with Safeset Reservoir – Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir; 03 ml Squeeze Flush and 6 Needle-Free Valves; Catalog No. 011-46106-22 Transpac Trifurcated Monitoring Kit with Safeset Reservoir; squeeze flushing and sampling port. The monitoring kit is used to measure and monitor fluid pressure; rehydration; and blood draw. The ICU is aware of a component problem where the connection on the arterial monitoring kit may break and cause fluid leakage.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated Monitoring Kit with Safeset Reservoir – Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP; With Velcro Arm Strap; Patient Mount; Item No. 011-46104-42 Transpac Trifurcated Monitoring Kit , With Safeset Reservoir; squeeze flushing and sampling port. The monitoring kit is used to measure and monitor fluid pressure; rehydration; and blood draw. The ICU is aware of a component problem where the connection on the arterial monitoring kit may break and cause fluid leakage.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated Monitoring Kit with Safeset Reservoir – Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir; 03 ml Squeeze Flush and 2 Clave Sampling Ports; Item No. 46112-52Transpac Trifurcated monitoring kit with Safeset Reservoir; squeeze flushing and sampling ports. The monitoring kit is used to measure and monitor fluid pressure, infusion, and blood draw. The ICU has realized that the connections on the arterial monitoring kit may rupture and cause problems with components that cause fluid leakage.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated Monitoring Kit with Safeset Reservoir-Arterial Transpac IT Monitoring Kit with Safeset Reservoir; 03 ml Irrigation Device and 2 CSPs; Catalog No. 011-46106-72 Transpac Trifurcated Monitoring Kit with Safeset Reservoir; squeeze flushing and sampling port. The monitoring kit is used to measure and monitor fluid pressure; rehydration; and blood draw. The ICU is aware of a component problem where the connection on the arterial monitoring kit may break and cause fluid leakage.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated Monitoring Kit with Safeset Reservoir – Transpac IT w/3 ML/HR Macrodrip; Arterial Pressure Tube and CSP; Catalog No. 011-46106-96 Transpac Trifurcated Monitoring Kit with Safeset Reservoir; Squeeze Pressure flushing and sampling ports. The monitoring kit is used to measure and monitor fluid pressure; rehydration; and blood draw. The ICU is aware of a component problem where the connection on the arterial monitoring kit may break and cause fluid leakage.

On August 8, 2014, Medtronic MiniMed Inc. Medtronic MiniMed Implantable Insulin Pump – Medtronic MiniMed Implantable Insulin Pump; Model MMT-2007D Medtronic MiniMed is recalling implantable insulin pumps because of reports that pump failures caused damage to the equipment. Insulin delivery is interrupted before the end of the 7-year service life.

August 8, 2014 Biosound Esaote; Inc. Esaote PA230E transducer – Esaote PA230E transducer is suitable for general and cardiovascular imaging portable and in-vehicle ultrasound systems using the PA230E transducer with user-defined settings, in 2D-TEI The output power is 100% (maximum) at the maximum depth of focus in the mode; it may cause the surface temperature of the transducer to exceed the maximum allowable limit.

August 8, 2014 Medtronic Neuromodulation Ascenda Intrathecal Catheter – Medtronic Ascenda Intrathecal Catheter Types 8780 and 8781; and Ascenda Intrathecal Catheter Pump Section Revision Kit; Model 8784. The Ascenda intrathecal catheter is part of the infusion system and is used to store and deliver parenteral drugs to the intrathecal space. The implantable infusion system components consist of a Medtronic pump and an Ascenda intrathecal catheter. Medtronic is removing specific batches of Ascenda intrathecal catheters and revision kits; used with implantable SynchroMed drug infusion pumps. The recall is due to a single component of the catheter; retaining ring; does not meet the regulatory standards. The pipe and the pump may be accidentally disconnected; or it is difficult to disconnect

Intuitive surgery on August 8, 2014; Inc. EndoWrist Stapler System User Manual Appendices and Wall Charts – EndoWrist Stapler System User Manual Appendices and Wall Charts; EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are designed to be compatible with the da Vinci Si Surgical System (IS3000 Type) together for resection; transect and/or create general anastomosis; gynecology and urology. The device can be used with staples or tissue support materials (natural or synthetic). Changes have been made to the appendix to the user manual of the stapler EndoWrist Stapler 45 System Instruments and Accessories (550986-03) and the EndoWrist Stapler 45 wall chart (PN 551524-01), in which the pH range specification of the enzyme cleaner used in the entire cleaning process From pH-neutral to pH-neutral to weak alkaline (weak alkaline is defined as pHd11). Mild alkaline enzyme

August 8, 2014 Abbott Molecular Abbott Molecular – 5 mL reaction vessel (consumable for the Abbott m2000sp automatic fluid handling system). The Abbott m2000 RealTime system is designed to be used for nucleic acid amplification tests by polymerase chain reaction in clinical laboratories. The system consists of m2000rt and m2000sp instruments. The Abbott m2000 real-time system is designed to be used for nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system consists of m2000rt and m2000sp instruments. Abbott Molecular has identified that some of the 5 ml reaction vessels (RV) contained in batch 56944001; 57026001; 57059001; and 57673001 (original supplier batch 2198077) may have insufficient rims. RVs with insufficient edges may not be firmly fixed in the 1 mL subsystem carrier. This may cause the RV to be incorrectly installed in the bracket or fall into the bracket.

August 8, 2014 Nanosphere; Inc. Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) – Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN); Use the sample-to-result Verigene system; Yes A qualitative multiple in vitro diagnostic test for simultaneous detection and identification of selected Gram-negative bacteria and drug resistance markers. BC-GN is carried out directly on the blood culture medium, using a blood culture bottle that is determined to be positive by the continuous monitoring blood culture system and contains Gram-negative bacteria confirmed by Gram staining. BC-GN can be used in conjunction with other clinical and laboratory test results to help diagnose bacterial bloodstream infections; however; it is not used to monitor these infections. Subculture of positive blood cultures is necessary for the recovery of microorganisms for antimicrobial susceptibility testing (AST); used to identify organisms not detected by BC-GN; detect mixed infections that may not be detected by BC-GN; use To associate antibiotic resistance marker genes with specific organisms; or for epidemiological typing. The BC-GN test is carried out on the Verigene System platform; this is a fully automated; desktop; molecular diagnostic workstation consisting of Verigene Reader and up to 32 Verigene Processor SP units. The system can detect bacterial DNA in blood cultures; unformed stool; or nasopharyngeal swabs; depending on the test; through automated nucleic acid extraction and hybridization. Nanosphere has determined that some BC-GN test cartridge lot numbers 040214021A have a high risk of no detection results and false negative results. The BC-GN test kit (20-006-021) is distributed as part of the Verigene BC-GN test kit (20-005-021); it is labeled "IVD". Therefore; Nanosphere has initiated a voluntary recall to recall the following BC-GN test boxes: Test Ca

August 10, 2014 Siemens Medical Solutions United States; Inc Siemens syngo RT Therapist and Syngo RT Oncologist – Siemens Syngo RT Therapist and Syngo RT Oncologist are expected to use the SIEMENS brand Syngo RT Therapist and Syngo RT Oncologist used with the SIEMENS series linear accelerator system The software application is radiotherapy that provides X-ray photons and electrons for the treatment of cancer. Siemens is aware of potential problems with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on the Siemens-branded LINAC system. These applications may experience sporadic system crashes, which may make it impossible to uninstall patient data.

August 10, 2014 Medtronic MiniMed Inc. Medtronic MiniMed Guardian Monitor – Medtronic MiniMed Guardian Monitor; Model CSS7100; CSS7100K Product use: Medtronic MiniMed Model CSS7100 and CSS7100K Guardian real-time monitors are used in combination with Minilink transmitter and Sof sensor glucose sensor. Continuously monitor the subcutaneous glucose concentration. The information provided by these devices is intended to be used to identify potential episodes of hyperglycemia or hypoglycemia. The information provided is not intended to be used directly for treatment adjustments, but to help users determine that additional fingertip blood glucose measurements may be appropriate. According to the product label; all treatment adjustments should be based on fingertip blood glucose measurements obtained using a standard home blood glucose meter, not based on sensor blood glucose values ​​provided by the Guardian real-time monitor. The CSS7100 and CSS7100K monitors are the same because the CSS7100K monitor is a pediatric version with a minimum programmable low alarm setting of 90 mg/dL. The minimum programmable hypoglycemia alarm setting for the adult model (CSS7100) is 40 mg/dL. Medtronic MiniMed is recalling Guardian Real-Time monitors because of manufacturing issues that may affect the water resistance of the affected Guardian monitors.

August 10, 2014 Carestream Health; Inc. Kodak DirectView DR 7500 diagnostic X-ray system – Kodak DirectView DR 7500 diagnostic X-ray system Product use: DR 7500 system is a permanently installed diagnostic X-ray system consisting of 4 main components Composition: Operator console; head tube crane; X-ray tube assembly including collimator and fixed generator. In addition, the equipment can use X-ray table and/or wall mount/bucky to complete X-ray exposure. The DR 7500 system is a permanently installed diagnostic X-ray system used to generate X-rays to examine various anatomical areas. Carestream Health (CSH) service engineering completed an on-site evaluation of the equipment components that connect the Beta components (X-ray tube and collimator) to the head tube crane (OTC) telescope. Inspection of these components showed that the tabs on the lock washer did not bend into the lock nut groove because the Beta component is separated from the OTC telescope; the lock nut is not

August 10, 2014 Siemens Medical Solutions United States; Inc Siemens Digital Linear Accelerators-ARTISTE Siemens linear accelerator; Anke; and PRIMUS with automated sequencing cancer treatment delivery options. This issue affects certain serial numbers of ARTIST-type digital linear accelerators (LINAC); Anke; and PRIMUS with automatic sequential therapy delivery options. The use of SIMTEC Auto Field Option’s automatic sorting treatment technology poses a security risk. During the automatic sorting treatment, the automatic movement of the gantry and the desktop may cause the co

Beer manufacturing and supply on August 10, 2014; Inc. Luma Wrap – Luma Wrap Phototherapy Swaddler aims to provide a centered and comfortable border as a benefit for restless babies in the neonatal intensive care unit. Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and sold without a 510(k) submission approved by the US FDA.

August 10, 2014 AGFA Healthcare Corp. DX-D 600-DX-D 600-DXD imaging package product use: used to provide diagnostic quality images to help doctors diagnose. The system can be used with MUSICA2 image processing to create radiographic images of bones including skull; spine and limbs; check the abdomen and two other parts. Some customers reported that when using the DX-D600 in a room or exam preparation; Overhead Tube Crane (OTC) showed increased speed and uncontrolled longitudinal movement.

August 11, 2014 ORTHO-CLINICAL DIAGNOSTICS VITROS immunodiagnostic product CA 19-9 reagent pack and CA 19-9 calibrator – VITROS immunodiagnostic product CA 19-9 calibrator and reagent pack; batch 1320 VITROS CA 19-9 reagent The package is used for the VITROS ECi/ECiQ immunodiagnostic system; the VITROS 3600 immunodiagnostic system and the VITROS 5600 integrated system are used to quantitatively measure the 1116-NS-19-9 antigen in human serum and plasma. Customers may receive positive deviations when using VITROS Immunodiagnostic Products CA 19-9 Total Reagent Packs; batch numbers 1320 and VITROS CA 19-9 calibrators; VITROS ECi/ECiQ immunodiagnostic system batch 1320; VITROS 3600 immunodiagnostics System and VITROS 5600 integrated system. Unexpected change observed in CA 19-9 calibrator; batch 1320 calibrator value.

August 11, 2014 Integra LifeSciences Corp. Integra NewPort MIS System – Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) NewPort System is intended to be used as a temporary or permanent rear ; Non-cervical implants to correct spinal diseases and stabilize the spine to allow the biological process of spinal fusion to occur. Integra LifeSciences is recalling the Integra NewPort MIS system because the components in the demo kit may be mixed with the NewPort MIS pedicle screw system components used in surgery.

August 12, 2014 Codman & Shurtleff; Inc. Codman Cetras-Codman Certas-online valve only; product code: 82-8800 Codman Certas programmable valve is an implantable device that provides constant intraventricular pressure and CSF (Cerebrospinal fluid) drainage, used to treat hydrocephalus. Clarified the CODMAN CERTAS Valve virtual close (setting 8) pressure specifications outlined in the product instructions for use (IFU).

August 12, 2014 Codman & Shurtleff; Inc. "Codman Cetras – Codman Certas – in-line valve used only with SIPHONGUARD device; product code: 82-8804 Codman Certas programmable valve is an implantable device that can be provided Constant intraventricular pressure and CSF (cerebrospinal fluid) drainage are used to treat hydrocephalus.” Clarify the CODMAN CERTAS Valve virtual closure (setting 8) pressure specifications outlined in the product instructions for use (IFU).

August 12, 2014 Codman & Shurtleff; Inc. "Codman Cetras-Codman Certas-tandem valve with integrated BACTISEAL catheter and accessories; product code: 82-8803 Codman Certas programmable valve is an implantable device, Provides constant intraventricular pressure and CSF (cerebrospinal fluid) drainage to manage hydrocephalus." Clarified the CODMAN CERTAS Valve virtual closure (setting 8) pressure specifications outlined in the product instructions for use (IFU).

August 12, 2014 Codman & Shurtleff; Inc. "Codman Cetras-Codman Certas-line valve with combined catheter and accessories; product code: 82-8802 Codman Certas programmable valve is an implantable device that provides constant Intraventricular pressure and CSF (Cerebrospinal Fluid) drainage are used to manage hydrocephalus.” Clarified the CODMAN CERTAS Valve Virtual Close (Setting 8) pressure specifications outlined in the Product Instructions for Use (IFU).

August 12, 2014 Codman & Shurtleff; Inc. Codman Cetras – Codman Certas – pipeline valve with SIPHONGUARD device; catheters and accessories; product code: 82-8805 Codman Certas programmable valve is an implantable device that can be provided Constant intraventricular pressure and CSF (cerebrospinal fluid) drainage are used to treat hydrocephalus. Clarified the CODMAN CERTAS Valve virtual close (setting 8) pressure specifications outlined in the product instructions for use (IFU).

August 12, 2014 Codman & Shurtleff; Inc. Codman Cetras-Codman Certas-In-line valve with SIPHONGUARD device; combined BACTISEAL catheter and accessories; Product code: 82-8807 Codman Certas programmable valve is an implantable device , Can provide constant intraventricular pressure and CSF (cerebrospinal fluid) drainage, used to treat hydrocephalus. Clarified the CODMAN CERTAS Valve virtual close (setting 8) pressure specifications outlined in the product instructions for use (IFU).

August 12, 2014 Codman & Shurtleff; Inc. Codman Cetras – Codman Certas – line valve with catheters and fittings; product code: 82-8801 Codman Certas programmable valve is an implantable device that provides a constant intracerebroventricular Pressure and CSF (cerebrospinal fluid) drainage are used to treat hydrocephalus. Clarified the CODMAN CERTAS Valve virtual close (setting 8) pressure specifications outlined in the product instructions for use (IFU).

August 12, 2014 Codman & Shurtleff; Inc. Codman Cetras – Codman Certas – line valve with SIPHONGUARD; modular catheters and accessories; product code: 82-8806 Codman Certas programmable valve is an implantable device that can be provided Constant intraventricular pressure and CSF (cerebrospinal fluid) drainage are used to treat hydrocephalus. Clarified the CODMAN CERTAS Valve virtual close (setting 8) pressure specifications outlined in the product instructions for use (IFU).

August 13, 2014 Brainlab AG Brainlab – Navigation Spine & Trauma 3D versions 2.0 and 2.1 are designed to be used as an intraoperative image-guided positioning system to achieve minimally invasive surgery. It is connected to a hand-drawn probe; the passive marker sensor system tracks the virtual computer image space on the 2D or 3D image data of the patient before or during the operation. The system is suitable for any medical conditions suitable for stereotactic surgery, as well as reference structures for rigid anatomical structures; such as skull; pelvis; can be relative to the acquired images (CT; MR; 2D fluoroscopy image or 3D fluoroscopy image reconstruction) and /Or to identify long bones or vertebrae based on the anatomical model of the image data. Brainlab navigation software Spine & Trauma 3D 2.0/2.1 provides automatic registration of CT image data sets acquired during surgery. Enable automatic registration; the software requires the rack position of the scanner. The gantry position can be entered manually or submitted automatically from the CT scanner. If automatic gantry communication is available; the so-called

August 13, 2014 Zimmer; Inc. Moore Hip Prosthesis Long Fenestrated Stem – Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 inches) head diameter 203 mm length. Product use: Moore hip prosthesis is a femoral prosthesis that can be used for X-ray imaging evidence of sufficient bone mass in the acetabulum and femoral neck that is satisfactory anywhere, and can be placed with or without bone cement. body. Due to the failure of the packaging design verification test, Zimmer is actively recalling 20 production batches of Moore hip joint prosthetic long fenestrated stems. Specifically; when the Moore hip bar damaged the inner or outer packaging tray, 9 out of 16 test samples failed the simulated distribution and transportation test. Zimmer has not received any complaints about damage to the packaging pallets of these 20 batches

August 13, 2014 Biomet; Inc. Distal Radius Fracture Repair System-Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate; Fixed; BoneDevice Generic Name: Drill Guide DNP 3.3mm Label: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy PO Box 988 Warsaw IN 46581 The company received a complaint that the drilling guide was stuck in the fixture. The drill guide can be placed in the fixture approximately halfway before jamming.

August 13, 2014 Gambro Kidney Products; merged with Gambro-Prismaflex M100. Product number 106697. Each set is packaged in plastic bags; 4 bags per carton. Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

August 13, 2014 Gambro Kidney Products; combined with Gambro – Prisma M60 post-dilution kit. Product number 104183. Each set is packaged in plastic bags; 4 bags per carton. Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

August 13, 2014 Gambro Kidney Products; merged with Gambro – Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in plastic bags; 4 bags per carton. Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

Gambro Kidney Products on August 13, 2014; merged with Gambro-Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic bag; 4 bags per carton Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

Gambro kidney products on August 13, 2014; merged with Gambro – Prismaflex TPE 2000 set; product number 1071441. Each set is packaged in plastic bags; 4 bags per carton. Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

August 13, 2014 Gambro Kidney Products; merged with Gambro – Prismaflex M60 set. Product number 106696. Each set is packaged in plastic bags; 4 bags per carton. Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

Gambro Kidney Products on August 13, 2014; Merged with Gambro – X-MARS set (part of MARS treatment kit type 1116/1 X-MARS US); liquid or blood leakage due to broken connector, product number 800541 Gambro vs Prisma And Prismaflex device launched an on-site operation.

August 13, 2014 Gambro Kidney Products; merged with Gambro-Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic bag; 4 bags per carton Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

Gambro Kidney Products on August 13, 2014; Merged Gambro – PrisMARS kit (part of MARS treatment kit type 1115/1 PrisMARS US); 1 MARS treatment kit per carton; product number 800480; liquid or damage caused by broken connectors The blood leaked and Batch Gambro launched an on-site operation against Prisma and Prismaflex devices.

August 13, 2014 Gambro Kidney Products; merged with Gambro – Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in plastic bags; 4 bags per carton. Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

August 13, 2014 Gambro Kidney Products; merged with Gambro – Prisma TPE 2000 set. Product number 109672. Each set is packaged in plastic bags; 4 bags per carton. Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

August 13, 2014 Gambro Kidney Products; merged with Gambro – Prisma M 100 PRE set. Product number 103657. Each set is packaged in plastic bags; 4 bags per carton. Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

Gambro kidney products on August 13, 2014; merge Gambro – Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in plastic bags; 4 bags per carton. Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

August 13, 2014 Gambro Kidney Products; merged with Gambro – Prisma M100 set. Product number 104182. Each set is packaged in plastic bags; 4 bags per carton. Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

Gambro Kidney Products on August 13, 2014; merged with Gambro-Prismaflex M150. Product number 109990. Each set is packaged in plastic bags; 4 bags per carton. Gambro launched an on-site operation on Prisma and Prismaflex devices because the connector was damaged and liquid or blood leaked.

August 13, 2014 Medical Positioning Inc Medical Positioning Rapid Response HUT table – Medical Positioning Rapid Response HUT table; electric medical examination table; model #1219. Product use: used to check syncope. Excessive weight on the table will cause the table with the affected parts to descend into Trendelenburg position faster than normal. The manufacturing components of this product may cause the equipment to malfunction.

August 13, 2014 Medical Positioning Inc Medical Positioning Rapid Response HUT table – Medical Positioning Rapid Response HUT table; electric medical examination table; model #1019. Product use: used to check syncope. Excessive weight on the table will cause the table with the affected parts to descend into Trendelenburg position faster than normal. The manufacturing components of this product may cause the equipment to malfunction.

August 13, 2014 Medical Positioning Inc. Medical Positioning Rapid Response HUT table – Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section; Electric medical examination table; Model #1217. Product use: Used for syncope check. Excessive weight on the table will cause the table with the affected parts to descend into Trendelenburg position faster than normal. The manufacturing components of this product may cause the equipment to malfunction.

August 13, 2014 Ortho-Clinical Diagnostics VITROS Calibration Data Module – VITROS Calibration Data Module (CDM PROM); catalog number 1999077; used in conjunction with VITROS Chemistry Products NH3 DT Slides; GEN 59 (reference/product code 1532589) and VITROS Chemistry Products DT Calibrator Kit 44 (reference/product code 1957927) is for in vitro diagnostics only. The Calibration Data Module (CDM) is an electronic device that contains analysis-specific data required to calibrate and use the analysis on the VITROS Chemistry Products DT60/DT60 II system. VITROS NH3 DT slides cannot be calibrated or used; GEN 59 and VITROS chemical products DT calibrator kit; when CDM PROM 0168 or 0169 is installed on the VITROS DT60/DT60 II chemical system, batch 44.

August 13, 2014 Medical Positioning Inc Medical Positioning Rapid Response HUT table – Medical Positioning Rapid Response HUT table; electric medical examination table; model #1017. Product use: used to check syncope. Excessive weight on the table will cause the table with the affected parts to descend into Trendelenburg position faster than normal. The manufacturing components of this product may cause the equipment to malfunction.

August 13, 2014 Nidek Inc GYC-1000 Green Laser Coagulator System – GYC-1000 Green Laser Coagulator System Nidek Green Laser Coagulator GYC-1000 is suitable for ophthalmic surgery; including retinal and macular photocoagulation; Iridotomy and trabeculoplasty. According to FDA regulations, laser aperture labels have not been applied to some GYC-1000 green laser photocoagulator equipment on site;

August 14, 2014 Nellcor Puritan Bennett Inc. (dba Covidien LP) Covidien – Vital Sync RMS 1.0 When loading the v2.4 software; packaged on a CD or other electronic control equipment. The CD is packaged in a clamshell jewelry box in a carton. The Vital Sync virtual patient monitoring platform is designed to be used by healthcare professionals for the following purposes: 1) remotely consult patient status; 2) remotely view near real-time patient data; waveforms and alarms, so that the information can be used to help clinical decision-making and provide timely Patient care. Due to the mismatch of the alarm priorities on the medical equipment and the Vital Sync system, Covidien is making on-site corrections to the Vital Sync virtual patient monitoring platform and informatics manager.

August 14, 2014 Nellcor Puritan Bennett Inc. (dba Covidien LP) Covidien – Vital Sync" VPMP & IM; software; V2.4. (DVD); packaged on a CD or other electronic control device. The CD is packaged in a clamshell The jewelry box in the middle carton. The Vital Sync virtual patient monitoring platform is designed to be used by healthcare professionals for the following purposes: 1) remotely consult patient status; and 2) remotely view near real-time patient data; waveforms and alarms in order to take advantage of these Information to help clinical decision-making and provide patient care in a timely manner. Covidien is making on-site corrections to the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager because of the medical equipment and the Vital Sync system.

August 14, 2014 Philips Medical Systems (Cleveland) IntelliSpace Portal DX/HX/EX; Smart Space Portal IX; and IntelliSpace Portal LX SPECT – IntelliSpace Portal (ISP) DX/HX/EX; Smart Space Portal (ISP) IX ; And IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multi-mode (CT, NM and MR) thin client application server that can provide enterprises with complete diagnostic viewing and clinical applications. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on the network. The system allows networking; selection; processing and shooting multi-modal DICOM images. The following software issues have been found in the affected products. Question 1: When reopening the bookmark generated by the MUGA (Multi-Gated Acquisition) scan in the NM Cardiac application; the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some cases; ejection fraction (

August 14, 2014 BioMerieux SA VIDAS D-dimer exclusion II – VIDAS D-dimer exclusion II; an automatic quantitative test for the VIDAS series of instruments for the use of enzyme-linked fluorescence detection technology in human plasma The fibrin degradation products were determined by immunoenzymatic method. It is also suitable for use in combination with pre-clinical probabilistic assessment models to exclude DVT and PE diseases. Customers complained that results below the detection limit (<45 ng/mL) were not repeatable. Therefore, the results near the 500 ng/mL medical decision point that were originally tested at <45 ng/mL reported false negatives.

August 14, 2014 Zimmer; Inc. Double Offset File Handle; Left Hand-Double Offset File Handle; Left Hand Nonsterile. Assembly; including the break of the leaf spring.

August 14, 2014 Zimmer; Inc. Version 2 D8L offset file handle; RT – VER2 D8L offset file handle; RTNonsterile The company received a complaint that due to various failure modes, the handle failed to maintain the The assembly of the file; including the break of the leaf spring.

August 14, 2014 Zimmer; Inc. 23.5-degree front supine double offset file handle – 23.5-degree file handle assembly-LEFTNonsterile The company received a complaint that the handle cannot be assembled with the file due to various failure modes during use ; Including the break of the leaf spring.

August 14, 2014 Zimmer; Inc. Double Offset File Handle; Right Hand-Double Offset File Handle; Right Hand Nonsterile. The company received a complaint that due to various failure modes, the handle cannot be kept assembled with the file during use ; Including the break of the leaf spring.

August 14, 2014 Zimmer; Inc. Version 2 DBL offset file handle; LT – VER2 DBL offset file handle; LTNonsterile The company received a complaint that due to various failure modes, the handle failed to maintain the The assembly of the file; including the break of the leaf spring.

August 14, 2014 Zimmer; Inc. Double offset file handle-version 1 with larger impact plate-Vl DBL OFFST WI LRG STPL; RTNonsterile The company received a complaint that the handle was in use due to various failure modes Failure to maintain the assembly with the file during the process; including breakage of the leaf spring.

August 14, 2014 Zimmer; Inc. 23.5 degree front supine double offset file handle-23.5 degree file handle assembly-RIGHTN is not sterile. The company received a complaint that the handle could not be maintained due to various failure modes during use Assembling with the file; including the break of the leaf spring.

August 14, 2014 Zimmer; Inc. Greatbatch double offset file handle; left hand-double offset file handle; Left HandA/S file handle (left) The company received a complaint that the handle was in use due to various failure modes Failure to maintain assembly to the file during the process; including breakage of the leaf spring.

August 14, 2014 Zimmer; Inc. Double Offset File Handle; Right Hand-Double Offset File Handle; Right Hand Nonsterile. The company received a complaint that due to various failure modes, the handle cannot be kept assembled with the file during use ; Including the break of the leaf spring.

August 14, 2014 Zimmer; Inc. Double Offset File Handle-Version 1 with larger impact plate-VI DBL OFFST W/ LRG STPL; LTNonsterile Failure to maintain the assembly with the file during use; including breakage of the leaf spring.

August 14, 2014 Zimmer; Inc. Double Offset File Handle-Version 2-PIN Rework-VER2 Handle; Pin Rework; RTNonsterile The company received a complaint that the handle failed during use due to various failure modes Keep the assembly with the file; including the break of the leaf spring.

August 14, 2014 Zimmer; Inc. Double Offset File Handle; Left Hand-Double Offset File Handle; Left Hand Nonsterile. Assembly; including the break of the leaf spring.

August 14, 2014 Zimmer; Inc. Double Offset File Handle; Left Hand-Double Offset File Handle; Left Hand Nonsterile. Assembly; including the break of the leaf spring.

August 14, 2014 Zimmer; Inc. Greatbatch double offset file handle; right hand-double offset file handle; Right HandA/S file handle (right) The company received a complaint that the handle was in use due to various failure modes Failure to maintain assembly to the file during the process; including breakage of the leaf spring.

August 14, 2014 Zimmer; Inc. Double Offset File Handle; Left Hand-Double Offset File Handle; Left Hand Nonsterile. Assembly; including the break of the leaf spring.

August 14, 2014 Zimmer; Inc. Double Offset File Handle-Version 2-PIN Rework-VER2 Handle; Pin Rework; LTNonsterile The company received a complaint that the handle failed during use due to various failure modes Keep the assembly with the file; including the break of the leaf spring.

August 14, 2014 Nanosphere; Inc. Nanosphere Verigene-Verigene BC-GN test kit (catalog number 20-005-021) includes: 1) 20 Verigene BC-GN test boxes. Each test box is pre-installed with all necessary reaction solutions; including washing solution; oligonucleotide probe solution and signal amplification solution required to produce test results. BC-GN can be used in conjunction with other clinical and laboratory test results to help diagnose bacterial bloodstream infections; however; it is not used to monitor these infections. Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-negative Blood Culture Nucleic Acid Test (BC-GN) extraction trays in batch 042914021B have low content or lack of magnetic particles (MMP) required for DNA extraction.

August 15, 2014 Omnilife Science Inc. Apex Arc hip stem; size 2; HA coating – Apex Arc hip stem; size 2; HA coating; product code: HC-21002-HA hip implant dyeing.

August 15, 2014 TomoTherapy Incorporated TomoTherapy Therapy System – TomoTherapy Therapy System; Model: Hi-Art; Catalog/Part Number: H-0000-0003; Software Version 1.2.0; 1.2.1 and 1.2.2 (Hi-Art 4.2.0; 4.2.1 and 4.2.2). Accuray voluntarily recalled TomoTherapy H series software version 1.2.0; 1.2.1 and 1.2.2 (Hi-Art 4.2.0; 4.2.1 and 4.2.2). Accuray has identified potential security issues (anomalies) in these software versions.

August 15, 2014 Biomet; Inc. Vanguard 360 Revision Knee System – Vanguard 360 Femur Boss Reamer; Label: REF 32-488474 VANGUARD 360 1NSTRUMENTFEMORAL BOSS REAMERNON-STERILE; BIOMET ORTHOPEDICS56 EAST BELL DRIVEP.O. Box 587 Warsaw; IN 46581 USA Vanguard 360 Femoral Boss Reamers manufactures the size to match the printed matter. The instrument may not be suitable for mating components.

August 15, 2014 TomoTherapy Incorporated TomoTherapy treatment system – TomoTherapy treatment system; Model: Hi-Art; Catalog/Part No: H-0000-0003; Software version 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). TomoTherapy treatment system is designed to be used as an integrated system for planning and precise implementation of radiotherapy; stereotactic radiotherapy; or stereotactic radiosurgery for tumors or other target tissues, while minimizing radiation transmission to important healthy tissues. Megavolt X-ray radiation is delivered in a rotating manner; non-rotating; modulated (IMRT); or non-modulated (non-IMRT/three-dimensional conformal) format, in accordance with the plan prescribed and approved by the doctor. Accuray voluntarily recalled TomoTherapy H series software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). Accuray has identified potential security issues (anomalies) in these software versions.

Siemens Medical Diagnostics on August 15, 2014; Inc. Dimension Clinical Chemistry System Cleaner – Siemens Dimension Chemical Cleaner (RD701) is an accessory for the flex cassette system used for Siemens Dimension RxL and Xpand testing. The cleaning buffer is used to clean the probe sensor between uses and prepare it for the next reading/measurement. Siemens Healthcare Diagnostics has received complaints about changes in the accuracy of QC's Dimension Chemistry Wash (RD701) and Troponin I patient sample results; CTNI (RF421C); LTNI (RF521C); Free T4; FT4 (RF410); Thyroid stimulation Hormone; TSH (RF412); N-terminal brain natriuretic peptide precursor; PBNP (RF423A) and LPBN (RF523A) chemical washing batch RD41041.Internal inv when using Dimension

August 16, 2014 Philips Healthcare Informatics; Inc. Philips IntelliSpace PACS 4.4 Image Management System-Philips IntelliSpace PACS 4.4 Image Management System performs digital image processing; measurement and communication and storage. A problem has been detected in the Philips IntelliSpace PAC 4.4 software if the patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS; unchanged data may be exported leading to the possibility of a diagnosis of incomplete data.

August 16, 2014 Zimmer; Inc. – 6.5 mm Cancellous Screw Full Thread Sterilezimmer Zimmer is recalling various trauma screws that failed the leak test only due to damage to the inner cavity.

August 16, 2014 Zimmer; Inc. – 6.5 mm cancellous screws 16 mm thread length Sterilezimmer Zimmer is recalling various trauma screws that failed the leak test only due to damage to the lumen.

August 16, 2014 Zimmer; Inc. – 4.0 mm cancellous screws; Partially ThreadedSterileZimmer Zimmer is recalling various trauma screws that failed the leak test due to internal damage.

August 16, 2014 Zimmer; Inc. Magna-Fx Hollow Screw Fixation System – Magna-Fx Hollow Screw Fixation System Bone Screw Full Thread Sterilezimmer Zimmer is recalling various trauma screws that failed the leak test only due to damage to the lumen.

August 16, 2014 Zimmer; Inc. – 6.5 mm cancellous screws 32 mm thread length Sterilezimmer Zimmer is recalling various trauma screws that failed the leak test only due to damage to the lumen.

August 16, 2014 Zimmer; Inc. Magna-Fx Hollow Screw Fixation System – Magna-Fx Hollow Screw Fixation System Hollow Bone Screw Sterilezimmer Zimmer is recalling various trauma screws that failed the leak test only because of damage to the lumen.

August 16, 2014 Zimmer; Inc. – Sterilezimmer 6.5 mm Fully Threaded Cancellous Screw Sterilezimmer Zimmer is recalling various trauma screws that failed the leak test only due to damage to the lumen.

August 16, 2014 Zimmer; Inc. – 4.5 mm Malleolar ScrewSterilezimmer Zimmer is recalling various trauma screws that failed the leak test due to damage to the lumen.

August 17, 2014 Ortho Development Corporation Tibial Insert CK-Tibial Insert CK; Balanced Knee System Modification; REF563-1YYY Product Usage: UHMWPE components used in the TKA and revised TKA procedures as the tibial bearing surface, when additional joints are required Articulation with femoral components under restraint Ortho Development is recalling various Pivot Bipolar Cups; patella; PS tibial insert; UC tibial insert; and CK Tibil Insert because the aluminum foil bag is not properly sealed; allowing air to infiltrate after the seal Back in the bag, this increases the risk that the material properties of the implant will be significantly reduced due to oxidation.

August 17, 2014 Ortho Development Corporation Pivot Bipolar Cup – Pivot Bipolar Cup 22×42/43-51/53mm; REF 133-YYYY Product Use: Used as a support surface in half joint replacement surgery, and CoCr Joint connection of femoral head and natural acetabulum Ortho Development is recalling various pivot bipolar cups; patella; PS tibial insert; UC tibial insert; and CK Tibil Insert because the aluminum foil bag is not properly sealed; allowing air after sealing Seepage back into the bag, which increases the risk that the material properties of the implant will be significantly reduced due to oxidation.

August 17, 2014 Smith and his nephew; Inc. TRIGEN(R) INTERTAN(TM) nails – TRIGEN(R) INTERTAN(TM) 10MM X 18 CM nails; 125o; reference number 71675201; quantity (1); sterile R Smith and Nephew; Memphis; Company; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM nails; 125o; REF 71675202; Quantity (1); Aseptic R; Smith and Nephew; Memphis; Company; TN 38116TRIGEN (R) INTERTAN(TM) 13MM X 18 CM nails; 125o; REF 71675203; Quantity (1); Sterile R; Smith and Nephew; Memphis; Company; TN 38116TRIGEN(R) INTERTAN(TM) 10MM X 20 CM nails; 125o; REF 71675204; quantity(1); sterile R; Smith and Nephew; Memphis; company; TN 38116TRIGEN(R) INTERTAN(TM) 11.5MM X 20 CM nails; 125o; REF 71675205; quantity(1); sterile R; Smith and Nephew; Memphis; Company; TN 38116TRIGEN(R) INTERTAN(TM) 13MM X 20 CM nails; 125o; REF 71675206; Quantity(1); Aseptic R; Smith and Nephew; Memphis; Company; TN 38116 TRIGEN (R) INTERTAN(TM) 10MM X 18 CM nails; 130o; REF 71675207; quantity(1); sterile R; Smith and Nephew; Memphis; company; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM Nail; 130o; REF 71675208; Quantity(1); Aseptic R; Smith and Nephew; Memphis; Company; TN 38116TRIGEN(R) INTERTAN(TM) 13MM X 18 CM Nail; 130o; REF 71675209; Quantity(1); None Bacteria R; Smith and Nephew; Memphis; Company; TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 20 CM Nail; 130o; REF 71675210; Quantity (1); Aseptic R; Smith and Nephew; Memphis; Company; TN 381 16TRIGEN(R) INTERTAN(TM) 11.5MM X 20 CM nails; 130o; reference number 71675211; quantity(1); sterile R; Smith and Nephew; Memphis; company; TN 38116TRIGEN(R) INTERTAN(TM) 13MM X 20 CM nail; 130o; reference number 71675212; quantity(1); sterile R; Smith and Nephew; Memphis; company; TN 38116TRIGEN(R) INTERTAN(TM) 10MM X 26 CM nail; 125o; left; reference number 71675213; Quantity(1); Aseptic R; Smith and Nephew; Memphis; Company; TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 32 CM nails; 125o; left; REF 71675219; Quantity(1); Aseptic R; Smith and nephew; Memphis; company; TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 34 CM nails; 125o; left; REF 71675221; quantity (1); sterile R; Smith and nephew; Memphis; company; TN 38116TRIGEN(R) INTERTAN(TM) 10MM X 34 CM nails; 125o; yes; reference number 71675222; quantity(1); sterile R; Smith and Nephew; Memphis; company; TN 38116TRIGEN(R) INTERTAN(TM) 10MM X 36 CM nails; left; 125o; REF 71675223; quantity(1); sterile R; Smith and Nephew; Memphis; company; TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 38 CM nails; 125o; left; Reference number 71675225; quantity(1); sterile R; Smith and Nephew; Memphis; company; TN 38116TRIGEN(R) INTERTAN(TM) 10MM X 40 CM nails; 125o; left; REF 71675227; quantity(1); none Bacteria R; Smith and Nephew; Memphis; Company; TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 40 CM Nail; 125o; Right; REF 71675228; Quantity (1); Aseptic R; Smith and Nephew; Memphis; Company ; TN 38116 TRIGEN(R) INTERTAN(TM ) 11.5MM X 28 CM nail; 125o; yes; REF 71675238; quantity(1); sterile R; Smith and Nephew; Memphis; company; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 32 CM nail; 125o ; Left; reference number 71675241; quantity(1); sterile R; Smith and Nephew; Memphis; company; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 34 CM nail; 125o; left; REF 71675243; Quantity(1); Aseptic R; Smith and Nephew; Memphis; Company; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 34 CM nails; 125o; Yes; REF 71675244; Quantity(1); Aseptic R; Smith and nephew; Memphis; company; TN 38116TRIGEN(R) INTERTAN(TM) 11.5MM X 36 CM nail; 125o; left; reference number 71675245; quantity (1); sterile R; Smith and nephew; Memphis; company; TN 38116TRIGEN(R) INTERTAN(TM) 11.5MM X 36 CM nail; 125o; yes; reference number 71675246; quantity(1); sterile R; Smith and nephew; Memphis; company; TN 38116 TRIGEN(R) INTERTAN(TM ) 11.5MM X 38 CM nail; 125o; left; REF 71675247; quantity(1); sterile R; Smith and Nephew; Memphis; company; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 38 CM nail; 125o; yes; REF 71675248; quantity(1); sterile R; Smith and Nephew; Memphis; company; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 40 CM nail; 125o; left; REF 71675249; quantity (1); Sterile R; Smith and Nephew; Memphis; Company; TN 38116TRIGEN(R) INTERTAN(TM) 11.5MM X 40 CM nail; 125o; Yes; REF 71675250; Quantity(1); Sterile R; Smith and Nephew; Memphis; Company; TN 38116TRIGEN(R) INTERTAN(T M) 10MM X 26 CM nail; 130o; left; REF 71675257; quantity (1); aseptic R; Smi manufacturing error occurred, resulting in incorrect positioning of the proximal lag screw hole in several batches of TRIGEN(R); INTERTAN(TM); nails.

August 17, 2014 Ortho Development Corporation Tibila Insert UC – Tibila Insert UC; Balanced Knee System; REF163-3YYY Product Usage: UHMWPE components used in TKA surgery are used as the joint joint of the tibial support surface and the femoral component. Ortho Development is recalling each Pivot Bipolar Cup; Patella; PS Tibial Insert; UC Tibil Insert; and CK Tibil Insert, because the aluminum foil bag is not properly sealed; allowing air to seep back into the bag after sealing, which will increase the material properties of the implant due to oxidation And significantly reduce the risk.

On August 17, 2014, Ortho Development Corporation Patella – Patella 38 mm; REF164-0038 Product use: UHMWPE components are used in TKA surgery to re-repair the surface of the patella and serve as the bearing surface for sliding contact with femoral components. Ortho Development is recalling various pivots Bipolar Cup; Patella; PS tibial insert; UC tibial insert; and CK Tibil Insert, because the aluminum foil bag is not properly sealed; allowing air to seep back into the bag after sealing, which will increase the material properties of the implant due to oxidation The risk is reduced.

August 17, 2014 Ortho Development Corporation PS Tibial Pad – PS Tibial Pad; REF 163-1XXX Product use: UHMWPE components used in TKA surgery as a tibial bearing surface for joint connection with femoral components Ortho Development is recalling various Pivot Bipolar Cup; Patella; PS Tibial Insert; UC Tibil Insert; and CK Tibil Insert, because the aluminum foil bag is not properly sealed; allowing air to seep back into the bag after sealing, which will increase the material properties of the implant due to oxidation Significantly reduced risk.

August 18, 2014 Inc. Uni*Fuse Infusion System with Cooper Wire – Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE; 5F x 90 cm x 10 cm infusion mode; Item No. /REF 12401806; Item No. H787124018065; Aseptic-Vascular Dynamics School; 603 Queensbury Avenue; Queensbury; NY 12804 AngioDynamics realizes that the Uni*Fuse infusion system with Cooper Wire may contain an incorrectly sized guide wire (too long).

August 18, 2014 Inc. Uni*Fuse Infusion System with Cooper Wire – Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE; 5F x 90 cm x 30 cm infusion mode; Item No. /REF 12401808; Item No. H787124018085; Aseptic-Vascular Dynamics School; 603 Queensbury Avenue; Queensbury; NY 12804 AngioDynamics realizes that the Uni*Fuse infusion system with Cooper Wire may contain an incorrectly sized guide wire (too long).

August 18, 2014 Inc. Uni*Fuse Infusion System with Cooper Wire – Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE; 5F x 90 cm x 40 cm infusion mode; Item No. /REF 12401809; Item No. H787124018095; Aseptic-Vascular Dynamics School; 603 Queensbury Avenue; Queensbury; NY 12804 AngioDynamics realizes that the Uni*Fuse infusion system with Cooper Wire may contain an incorrectly sized guide wire (too long).

August 18, 2014 Ltd. Gelweave (TM) Vascular Prosthesis – Gelweave (TM) Vascular Prosthesis Manufacturer – VASCUTEK Ltda TERUMO compared to grafts (4 and 5 years respectively).

August 18, 2014 Medtronic Neuromodulation Activa PC – Medtronic; Activate the computer; Model 37601; Sterilization method: ethylene oxide; For single use only; Accept only. The Activa PC neurostimulator is a two-channel device that can provide bilateral stimulation. The Activa PC contains non-rechargeable batteries and microelectronic circuits that can deliver controlled electrical pulses to precise target areas of the brain. The device is usually implanted subcutaneously near the collarbone; connected to extensions and leads; they are implanted in the brain. Medtronic is recalling six Activa PC (model 37601) implantable neurostimulators because the electronic components may be damaged during the manufacturing process.

August 18, 2014 Biolase Technology Inc WaterLase iPius – WaterLase iPlus dental laser system; part number 7200854-XX software upgrade kit; part number 6201463. Due to differences in the user interface software (version 1.7), Biolase is recalling the WaterLase iPlus dental laser system. If an error occurs on the program screen; the air setting will be changed to 1% and closed.

Hyperion Medical HyperBlue 1530 on August 18, 2014; Multi-Purpose Diode Laser-all brochures printed before November 20; 2013 for HyperBlue 1530; including product brochures and related information on www.hyperionMed.com before December 3 Online information about the product; 2013. The brochures and website information of the Hyper blue 1530 diode laser advertise features that have not been cleared by the FDA before the product is marketed. Specifically; the website and brochure incorrectly label the product, claiming that it can use 940 nm; 808 nm; and 532 nm wavelengths as a single wavelength or in combination with other wavelengths; and claiming the product

Synthesized on August 19, 2014; Inc. Synthes 3.0 MM TI Hollow Screw Instruments and Implant Kits – Synthes 3.0 MM TI Hollow Screw Instruments and Implant Kits The screw kit was returned from the site for destruction after exposure to flooding; it was mistakenly rebuilt Process and return to the scene. Preliminary investigation tests indicate that the components in this group may be cytotoxic.

August 19, 2014 Gyrus Medical; Inc Falope-Ring Dilator – Gyrus ACMI Falope-Ring Dilator; Project 000878-4. The Falope-Ring dilator is a tapered plastic device that is part of the Falope-Ring ring-band contraceptive occlusion device surgical kit (FRB-30). The Falope-Ring Band contraceptive fallopian tube occlusion device (TOD) consists of a cylindrical radiopaque silicone band. When placed on the ring segment of the fallopian tube, the silicone band will block the lumen of the fallopian tube. FRB-30 (used with reusable applicator) consists of a reusable Falope-Ring Guide; a manual and 30 program packages. Each kit is provided aseptically and includes a dilator and two Falope belts. The Falope-Ring dilator for the reusable Falope-Ring Band applicator has been sold as a separate non-sterile component. The expander is designed to help place the Falope-Ring tape on the reusable Falope applicator.

August 19, 2014 Intelerad Medical Systems IntelePACS – IntelePACS software versions 3-8-1 to 4-9-1; product use: IntelePACS is a device that receives digital images and data from various sources (for example, CT scanners) ; MRI scanners; ultrasound systems; R/F devices; computers and direct radiography equipment; secondary capture equipment; scanners; imaging gateways; or other image sources. Under certain circumstances, partially truncated files may be written to IntelePACS Server. This partially truncated file can still be viewed by InteleViewer, and InteleViewer will report to the user that the file in question is complete. This happens only when the file is partially truncated.

On August 19, 2014, Ansar Group; Inc. Dba Ansar Medical Technologies; Inc. ANSAR ANX-3.0 autonomous monitoring system-the blood pressure (BP) circuit of the ANSAR ANX-3.0 autonomous monitoring system. The ANX 3.0 system consists of multiple FDA 510 K market-approved components. The components are as follows: 1. Patient physiological monitor; 2. Notebook computer; 3. Bracket with wheels; 4. Patient cable; 5. Software components (respiratory and cardiac spectrum frequency signal processor). The different monitor components that can be used in the system are one of the following for each system: Patient physiological monitor used: CJPS Vital Pro; No. 510 K K001775; Zoe Medical Nightingale Monitoring System; No. 510 K; Ivy Bio Medical model 405P; K955546; software components: Ansar ANS C 3000; K941252 The device is also called ANS-C3000 Ansar Group; Inc. recalled the blood pressure (BP) circuit of the ANSAR ANX-3.0 autonomous monitoring system because some people complained that it occasionally failed Inflate the blood pressure cuff, and the BP circuit cannot be activated; resulting in no blood pressure measurement.

August 19, 2014 Invivo Corporation Philips Expression IP5 Information Portal-Philips IP5 Information Portal Expression Information Portal (model IP5); display and device controller for Philips MRI patient monitoring systems; designed for use by trained healthcare professionals To remotely monitor the vital signs of patients undergoing MRI surgery. The wireless function of the IP5 radio may be interrupted, causing the loss of wireless communication between the IP5 and the host monitoring system.

August 20, 2014 GE Healthcare; LLC Discovery XR656 – GE Healthcare; Discovery XR656P/N 5374989/5397837 Designed to generate digital radiographic images of the skull; spine; chest; abdomen; limbs and other body parts of patients of all ages. GE Healthcare has become aware of a potential safety issue involving the nylon hooks that support the FlashPad" detector on the Discovery XR656 wall mount system. There have been reports of falling detectors; but no reports of injuries.

Zimmer, August 20, 2014; Inc. PERSONA (TM) – PERSONA (TM) personalized knee joint system tibia universal instrument tray; the intended use of the non-sterile sterilization box is tissue; according to a typical hospital or surgical center Circulation (ie between the central service and the operating room) and during transportation between Zimmer distributors and healthcare facilities by Zimmer distributor personnel, store and protect its contents from damage. The company found that current personal tibia/universal fixation trays may not have a specific geometry to accommodate tibia drills and stop guides in the correct position/orientation. The geometry of the drill holder and drill guide is incorrect and cannot be installed correctly in the Persona Fixing Box Kit, which may cause improper disinfection of the tibial drill and stop guide.

Zimmer, August 20, 2014; Inc. PERSONA (TM) – PERSONA (TM) personalized knee joint system tibia universal instrument tray; the intended use of the non-sterile sterilization box is tissue; according to a typical hospital or surgical center Circulation (ie between the central service and the operating room) and during transportation between Zimmer distributors and healthcare facilities by Zimmer distributor personnel, store and protect its contents from damage. The company found that current personal tibia/universal fixation trays may not have a specific geometry to accommodate tibia drills and stop guides in the correct position/orientation. The geometry of the drill holder and drill guide is incorrect and cannot be installed correctly in the Persona Fixing Box Kit, which may cause improper disinfection of the tibial drill and stop guide.

August 20, 2014 ICU Medical; Inc. MicroClave-cap replacement kit with MicroClave transparent connector; catalog number B79103BD pre-filled syringes are packaged in one kit with ICU equipment and other components. The batch number printed on the bag makes it easy to identify the affected batch. ICU Medical is recalling BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may have openings and seals, which will affect the sterility of the packaging and potential product sterility.

August 20, 2014 ICU Medical; Inc. MicroClave-CAP replacement kit with MicroClave Clear; Item No. B78109BD pre-filled syringes are packaged in one kit with ICU equipment and other components. The batch number printed on the bag makes it easy to identify the affected batch. ICU Medical is recalling BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may have openings and seals, which will affect the sterility of the packaging and potential product sterility.

August 20, 2014 ICU Medical; Inc. MicroClave-port access kit with MicroClave transparent connector; catalog number B79104BD pre-filled syringes are packaged in one kit with ICU equipment and other components. The batch number printed on the bag makes it easy to identify the affected batch. ICU Medical is recalling BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may have openings and seals, which will affect the sterility of the packaging and potential product sterility.

August 21, 2014 Pentax Medical Company Pentax Medical Inc. – PENTAX upper/lower gastrointestinal endoscope OF-B130 and OF-B194 gas/water supply valve Pentax OF-B130 and OF-B194 gas/water valve instruction IFU If it is not followed carefully, it may pose a potential risk to health.

August 21, 2014, Zimmer; Inc. Persona TASP PS – Persona (TM) Personalized Knee System PS TopNonsterile TASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3 -5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6 -9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF T OPTASP PS L 3-5 EF TOPTASP PS L 3 -5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6 -9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6- 9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6 -9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10- 11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 6 -9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6- 9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10 -12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10- 12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTA SP PS L 10-12 J TOPTASP PS L 10-12 J TOPTASP PS L 10-12 J TOPTASP PS L 10-12 J TOPTASP PS L 10-12 J TOPTASP PS L 10-12 J TOPTASP PS L 10-12 J TOP Zimmer Joint test The joint face-to-time material (TASP) is broken. This is a retrospective recall that covers the corrective actions Zimmer took in response to TASP earlier this year.

August 21, 2014, Zimmer; Inc. Persona TASP – Persona (TM) Personalized Knee System CPS TopNonsterile TASP MLC L 3-5 CD TOPTASP MLC L 6-9 CD TOPTASP MLC L 3-5 EF TOPTASP MLC L 6-9 EF TOPTASP MLC L 10- 11 EF TOPTASP MLC L 6-9 GH TOP Zimmer received a complaint that the Persona Knee Trial joint facing material (TASP) was damaged. This is a retrospective recall that covers the corrective actions Zimmer took in response to TASP earlier this year.

August 21, 2014, Zimmer; Inc. Persona TASP – Persona (TM) The Personalized Knee System UC TopNonsterile TASP UC L 3-7 CD TOPTASP UC L 4-11 EF TOPTASP UC L 7-12 GH TOPTASP UC L 9-12 J TOP Zimmer has received a complaint reporting damage to the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall that covers the corrective actions Zimmer took in response to TASP earlier this year.

August 21, 2014, Zimmer; Inc. Persona TASP – Persona (TM) Personalized Knee System Tibial Joint Facing Non-sterile TASP L CD BOTTOM; 0MMTASP L CD Bottom; 6MMTASP L EF Bottom; 0MMTASP L EF Bottom; 6MMTASP L GH bottom; 0MMTASP L GH bottom; 6MMTASP LJ bottom; 0MMTASP LJ bottom; 6MMTASP R CD bottom; 0MMTASP R CD bottom; 6MMTASP R EF bottom; 0MMTASP R EF bottom; 6MMTASP R GH bottom; 0MMTASP R GH bottom; 0MMTASP R GH bottom; 0MMTASP R GH bottom; 6MMTASP RJ bottom; 0MMTASP RJ bottom; 6MM Zimmer has received complaints, reports that the Persona knee joint test joint is facing time component (TASP) damage. This is a retrospective recall that covers the corrective actions Zimmer took in response to TASP earlier this year.

August 21, 2014, Zimmer; Inc. Persona TASP-Persona (TM) Personalized Knee Joint System CR Tibia Joint Faced TopNonsterile TASP CR L 3-9 CD TOP Zimmer Received a complaint that Persona Knee Joint Experimental Joint Facing timeliness (TASP) breakage. This is a retrospective recall that covers the corrective actions Zimmer took in response to TASP earlier this year.

August 21, 2014, Zimmer; Inc. Persona TASP – Persona (TM) Personalized Knee System Non-sterile PSN A/S PROV L CD BOTTOM 0MMPSN A/S PROV L CD BOTTOM 6MMPSN A /S PROV L EF BOTTOM 0MMPSN A/S PROV L EF bottom 6MMPSN A/S PROV L GH bottom 0MMPSN A/S PROV L GH bottom 6MMPSN A/S PROV LJ bottom 0MMPSN A/S PROV LJ bottom 6MMPSN A/S PROV R CD bottom 0MMPSN A/S PROV R CD bottom 6MMPSN A/S PROV R EF bottom 0MMPSN A/S PROV R EF bottom 6MMPSN A/S PROV R GH bottom 0MMPSN A/S PROV R GH bottom 6MMPSN A/S PROV RJ bottom 0MMPSN A/S PROV RJ BOTTOM 6MM Zimmer received a complaint that the Persona Knee Trial Articular Surface Provisionals (TASP) was damaged. This is a retrospective recall that covers the corrective actions Zimmer took in response to TASP earlier this year.

August 21, 2014 Philips Medical Systems; Inc. Philips IntelliSpace ECG management system-Philips IntelliSpace ECG management system; with software option C61 required to import ECG from Quinton pressure ECG system. Model 860426 Philips IntelliSpace electrocardiogram (IECG) management system imports pressure electrocardiogram records from Quinton pressure electrocardiogram system. Patient records may contain multiple and therefore inaccurate patient identifiers, such as: patient name; patient ID (PID); medical record number (MRN). This creates the possibility of misdiagnosis and incorrect treatment.

August 22, 2014 Medtronic MiniMed Inc. Medtronic MiniMed Paradigm REAL-Time and Paradigm REAL-Time Revel CGM system and MiniMed 530G system – Medtronic MiniMed Paradigm insulin infusion pump; paradigm model: MMT-511; MMT-512; MMT-712 ; MMT-712E; MMT-515; MMT-715; MMT-522; MMT-522K; MMT-722; MMT-722K; MMT-523; MMT-523K; MMT-723; MMT-723K; MMT-554; and MMT-754.MiniMed 530G: MMT-551; and MMT-751 Paradigm insulin infusion pump is designed to deliver basic and bolus insulin to diabetic patients. Medtronic is recalling the Medtronic MiniMed Paradigm insulin infusion pump because they have received reports that users accidentally programmed the pump to provide the maximum dose.

August 22, 2014 Zimmer; Inc. Persona distal valgus alignment guide – PERSONA distal valgus alignment guide; non-sterile quantity 1 *** Zimmer Warsaw; 46580; US this device before initial femoral resection Set the correct varus/valgus alignment of the patient's knee. The Persona distal valgus alignment guide chuck lock is stuck in the "unlocked" position.

August 22, 2014 Becton Dickinson & Company Becton Dickinson & Company – BD Vacutainer CPT cell preparation tube with heparin sodium; 8 ml; 16 x 125 mm; catalog #REF 362753; batch number #4063409, valid for 03/2015; for Collect whole blood and separate monocytes. Due to poor separation, BD has begun to recall its Vacutainer CPT cell preparation tubes; resulting in a reduction in the number of recovered monocytes.

August 26, 2014, Zimmer; Inc. Zimmer Patello-Femoral Joint (PFJ) Prosthesis-Gender Solution Patello-Femoral Joint System Patello-Femoral TrochleaComponent; pre-coated; size 4; left product use: Zimmer Patello-Femoral Joint (PFJ) The prosthesis is designed to closely replicate the anatomical features of the patellar groove on the femur. The implant articular surface incorporates the frontal contour geometry of the NexGen knee system for optimal patella tracking with and without resurfaced patella. The structure of the PFJ prosthesis is suitable for a wide range of patients; women and men. The implant provides five sizes of left and right configurations. It is possible to use:? Osteoarthritis; traumatic arthritis; polyarthritis; and/or severe chondrocalcinosis of the patellofemoral joint;? Rescue previously failed surgical attempts (eg; arthroscopy; lateral lysis; cartilage transplantation) ;? History of patella dislocation or patella fracture;? Degeneration caused by dysplasia The device is for bone cement only. The internal review found that five (5) PFJ implant forgings were determined to have forged laps during the raw material acceptance inspection process. These five forgings were not separated and were subsequently manufactured according to part 00-5926-014-01; batch number 62455332. Forging overlap is a defect that is formed when metal folds on itself during the forging process.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter sizes: 11.0 and 11.5 Product use: AMO TECNIS CL single-focal foldable intraocular lens adopts OptiEdge design, is a posterior chamber intraocular lens that absorbs ultraviolet rays, and can compensate for spherical corneal aberration. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm, with the following diopter size: 18.5-19.0 Product use: AMO TECNIS CL single-focal foldable intraocular lens adopts OptiEdge design, is a posterior chamber intraocular lens that absorbs ultraviolet light, which can compensate for spherical corneal aberration. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter sizes: 23; 23.5 & 24. Product use: AMO TECNIS CL single-focus foldable intraocular lens adopts OptiEdge design. It is a posterior chamber intraocular lens that absorbs ultraviolet rays and can compensate for spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter sizes: 29; 29.5 & 30. Product use: AMO TECNIS CL single-focus foldable intraocular lens adopts OptiEdge design. It is a posterior chamber intraocular lens that absorbs ultraviolet light and can compensate for spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter dimensions: 16.5; 17.0 Product use: The AMO TECNIS CL single-focal foldable intraocular lens designed with OptiEdge is a posterior chamber intraocular lens that absorbs ultraviolet rays, which can compensate for spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter sizes: 12.0 and 12.5 Product use: AMO TECNIS CL single-focal foldable intraocular lens adopts OptiEdge design. It is a posterior chamber intraocular lens that absorbs ultraviolet light and can compensate for spherical corneal aberration. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter sizes: 26.5; 27; 27.5 & 28.5. Product use: AMO TECNIS CL single-focus foldable intraocular lens adopts OptiEdge design. It is a posterior chamber intraocular lens that absorbs ultraviolet light and can compensate for spherical corneal aberration. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter dimensions: 15.5; 16.0 Product use: The AMO TECNIS CL single-focal foldable intraocular lens designed by OptiEdge is a posterior chamber intraocular lens that absorbs ultraviolet rays, which can compensate for spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter size: 21.5-22.5 Product use: AMO TECNIS CL single-focal foldable intraocular lens adopts OptiEdge design. It is a posterior chamber intraocular lens that absorbs ultraviolet rays and can compensate for spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter dimensions: 14.5; 15.0 Product use: The AMO TECNIS CL single-focal foldable intraocular lens designed with OptiEdge is a posterior chamber intraocular lens that absorbs ultraviolet rays, which can compensate for spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter sizes: 24.5; 25; 25.5 & 26. Product use: AMO TECNIS CL single-focus foldable intraocular lens adopts OptiEdge design. It is a posterior chamber intraocular lens that absorbs ultraviolet light and can compensate for spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter sizes: 13.0; 13.5; 14.0 Product use: The AMO TECNIS CL single-focal foldable intraocular lens designed with OptiEdge is a posterior chamber intraocular lens that absorbs ultraviolet light, which can compensate for spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter dimensions: 17.5; 18.0 Product use: The AMO TECNIS CL single-focal foldable intraocular lens designed with OptiEdge is a posterior chamber intraocular lens that absorbs ultraviolet rays, which can compensate for spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter sizes: 10.0 and 10.5 Product use: AMO TECNIS CL single-focal foldable intraocular lens adopts OptiEdge design. It is a posterior chamber intraocular lens that absorbs ultraviolet light and can compensate for spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter size: 19.5-20 Product use: AMO TECNIS CL single-focal foldable intraocular lens adopts OptiEdge design. It is a posterior chamber intraocular lens that absorbs ultraviolet light and can compensate for spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter size: 20.5-21 Product use: AMO TECNIS CL single-focal foldable intraocular lens adopts OptiEdge design, is a posterior chamber intraocular lens that absorbs ultraviolet light, which can compensate for spherical corneal aberration. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

Made by AMO Puerto Rico on August 26, 2014; Inc. TECNIS CL-AMO TECNIS CL foldable silicone intraocular lens with OptiEdge design; model Z9002. It is suitable for the first implantation of aphakic vision correction in adult patients. Tecnis CL Mono 13 mm has the following diopter dimensions: 5.0; 5.5; 6.0; 6.5; 7.0; 7.5; 8.0; 8.5; 9.0; 9.5 Product use: AMO TECNIS CL OptiEdge designed single-focal foldable intraocular lens is a posterior room that absorbs ultraviolet light The intraocular lens can compensate the spherical aberration of the cornea. TECNIS CL silicone intraocular lens is suitable for initial implantation and is used for aphakic vision correction in adult patients who have removed the cataract lens by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the pouch. AMO voluntarily recalled a large number of silicone intraocular lenses with OptiEdge design (Z9002 type) because these intraocular lenses may be marked with incorrect diopters.

August 26, 2014, Zimmer; company Moore and Thompson hip stems - Moore and Thompson hip stems: FNSTRD HIP 38HDX127STFNSTRD HIP 40HDX127STFNSTRD HIP 41HDX127STFNSTRD HIP 42HDX127STFNSTRD HIP 43HDX127STFNSTRD HIP 44HDX127STFNSTRD HIP 45HDX140STFNSTRD HIP 46HDX140STFNSTRD HIP 47HDX140STFNSTRD HIP 48HDX140STFNSTRD HIP 49HDX140STFNSTRD HIP 50HDX152STFNSTRD HIP 51HDX152STFNSTRD HIP 52HDX152STFNSTRD HIP 53HDX152STFNSTRD HIP 54HDX152STFNSTRD HIP 55HDX152STFNSTRD HIP 57HDX152STFNSTRD HIP 60HDX152STFNSTRD HIP 63HDX152STFNSTRD HIP 38HDX140STFNSTRD HIP 40HDX140STFNSTRD HIP 41HDX140STFNSTRD HIP 42HDX140STFNSTRD HIP 43HDX140STFNSTRD HIP 44HDX140STFNSTRD HIP 45HDX152STFNSTRD HIP 46HDX152STFNSTRD HIP 47HDX152STFNSTRD HIP 48HDX152STFNSTRD HIP 49HDX152STFNSTRD HIP 50HDX152STFNSTRD HIP 51HDX152STHIP PROS 38HDX105STHIP PROS 40HDX105STHIP PROS 41HDX105STHIP PROS 42HDX105STHIP PROS 43HDX105STHIP PROS 44HDX105STHIP PROS 45HDX105STHIP PROS 46HDX105STHIP PROS 47HDX105STHIP PROS 48HDX105STHIP Professional Edition 49HDX105STHIP Professional Edition 50HDX105STHIP Professional Edition 51HD X105STHIP PROS 52HDX105STHIP Sightseeing 5 Sightseeing 60HDX105STHIP sightseeing 57HDX105STHIP sightseeing 55HDX105STHIP sightseeing 54HDX105STHIP of 3HDX105STHIP sightseeing 63HDX105STFNSTRD HIP 38HDX165STFNSTRD HIP 40DX165STFNSTRD HIP 41HDX165STFNSTRD HIP 42HDX165STFNSTRD HIP 43HDX165STFNSTRD HIP 44HDX165STFNSTRD HIP 45HDX165STFNSTRD HIP 46HDX165STFNSTRD HIP 47HDX165STFNSTRD HIP 48HDX165STFNSTRD HIP 49HDX165STFNSTRD HIP 50HDX191STFNSTRD HIP 51HDX191STFNSTRD HIP 52HDX191STFNSTRD HIP 53HDX191STFNSTRD HIP 54HDX191STFNSTRD HIP 55HDX191STFNSTRD HIP 57HDX191STFNSTRD HIP 60HDX191STFNSTRD HIP 63HDX191STFNSTRD HIP 38HDX165STFNSTRD HIP 41HDX165STFNSTRD HIP 43HDX165STFNSTRD HIP 44HDX165STFNSTRD HIP 46HDX165STFNSTRD HIP 48HDX165STFNSTRD HIP 49HDX165STFNSTRD HIP 51HDX165STHIP PROS 38HDX127STHIP PROS 40HDX127STHIP PROS 41HDX127STHIP PROS 42HDX127STHIP PROS 43HDX127STHIP PROS 44HDX127STHIP PROS 45HDX140STHIP PROS 46HDX140STHIP PROS 47HDX140STHIP PROS 48HDX140STHIP PROS 49HDX140STHIP PROS 50HDX152STHIP PROS 51HDX152STHIP PROS 52HDX152STHIP PROS 53HDX152STHIP PROS 54HDX152STHIP PROS 55HDX152STH IP PROS 57HDX152STHIP PROS 60HDX152STHIP PROS 63HDX152STHIP PROS 38HDX165STHIP PROS 40HDX165STHIP PROS 41HDX165STHIP PROS 42HDX165STHIP PROS 43HDX165STHIP PROS 44HDX165STHIP PROS 45HDX165STHIP PROS 46HDX165STHIP PROS 47HDX165STHIP PROS 48HDX165STHIP PROS 49HDX165STHIP PROS 50HDX191STHIP PROS 51HDX191STHIP PROS 52HDX191STHIP PROS 53HDX191STHIP PROS 54HDX191STHIP PROS 55HDX191STHIP PROS 57HDX191STHIP PROS 60HDX191STHIP PROS Because packaging design verification The test failed and 63HDX191ST Zimmer is recalling aseptic packaged implants and devices in six different packaging configurations. Specifically; when the device damaged the internal or external packaging tray or lost the integrity of the seal, multiple test samples from each of the six configurations failed to pass the simulated distribution and transportation tests.

August 26, 2014, Zimmer; The company's traumatic screw-traumatic screw: CANN bone screw 7.0MMX100MMLGCANN bone screw 7.0X105LGCANN bone screw 7.0X105LGCANN bone screw 7.0MMX105MMLGCANN bone screw 7.0X110LGCANN bone screw 7.0X110LGCANN bone screw 7.0MMX110MMLGCANN bone screw 7.0X115LGCANN Bone Screw 7.0X115LGCANN Bone Screw 7.0 MMX115MMLGCANN Bone Screw 7.0X120LGCANN Bone Screw 7.0X120LGCANN Bone Screw 7.0MMX120MMLGCANN Bone Screw 7.0X125LGCANN Bone Screw 7.0MMX125MMLGCANN Bone Screw 7.0X130LGCANN Bone Screw 7.0MMXRECON105MMRECON SCR LGE 5.5MMDX105MMRECON SCR LGE 5.5MMDX105MM LCRGE 5.5MMRE SCR LGE 5.5MMDX120MMRECON SCR LGE 5.5MMDX125MMRECON SCR LGE 5.5MMDX130MMITST Anti-corrosion SCR 6.5MMDX105MMITST Anti-corrosion SCR 6.5MMDX110MMPERI. SCR 3.5MM X105MMLPERI SCR. 6.5MM X 100MM LPERI SCR. 6.5MM X 140MM LPERI SCR. 6.5MM X 100MM LPERI SCR. 6.5MM X 100MM L3.5MM CORT SCR X 105MM SELFTAP3.5MM CORT SCR X 110MM SELFTAP5.5MM X 100MM CANN LKNG SCREWZ NAIL 6.0 X 105 CANC SCREW PTZ NAIL 6.0 CANC X SCREW 1W X.0 CANC Z SCRE1W 1W 120 CANC screw PTZ NAIL 6.0 X 125 CANC screw PTZ NAIL 6.0 X 130 CANC screw PTZ NAIL 6.0 X 135 CANC screw PTZ NAIL 6.0 X 140 CANC screw PTZ SCREW XNC SCREW PTZ NAIL 10 X FAZ 10. NAIL 10 FAZ 10 16 FAZ CANC screw FAZ NAIL 6.0 X 120 CANC SCREW FAZ NAIL 6.0 X 125 CANC SCREW FAZ NAIL 6.0 X 130 CANC SCREW FAZ NAIL 6.0 X 135 CANC SCREW FAZ NAIL 6.0 X SCREW FAZ CANC FAZ SCREW 140 150 AZ 140 CANC SCREW FAZ NAIL CANC PTZ NAIL 6.0 X 115 CANC SCREW PTZ NAIL 6.0 X 120 CANC SCREW PTZ NAIL 6.0 X 125 CANC SCREW PTZ NAIL 6.0 X 130 CANC SCREW PTZ NAIL 6.0 X NC SCREW 10 X NC SCREW 10 X NC SCREW 130 X NC SCREW PTZ NAIL 130.5 FAZ NAIL 6.0 X 110 CANC SCREW FAZ NAIL 6.0 X 115 CANC SCREW FAZ NAIL 6.0 X 120 CANC SCREW FAZ NAIL 6.0 X 125 CANC SCREW FAZ NAIL 6.0 X 130 CANC SCREW FAZ NAIL 6.0 X 135 CANC screw FAZ NAIL 6.0 X 140 CANC screw FA3.5X105 CORT SCR3.5 X 105 CORT SCR SELF TAP3.5X110 CORT SCR3.5 X 110 CORT SCR SELF TAP3.5XRTX113 CO. TAP3.5X120 CORT SCR3.5 X 120 CORT SCR SELF TAP3.5X125 CORT SCR3.5X130 CORT SCR3.5X135 CORT SCR3.5X140 CORT SCR3.5X145 CORT SCR3.5X150 CORT SCR15 CORT 1050 CORT X.5X155 CORT SCR15 CORT1LFAP SCR SELF TAP4.5 X 120 CORT SCR SELF TAP6.5X105 CANC SCR; full THDED6.5X105 CANC SCR; 16MM THD6.5X105 CANC SCR; 32MM THD6.5X110 CANC SCR; full THDED6.5X110 CANC SCR; 16MM THD6.5X110 CANC SCR; 32MM THD6.5X115 CANC SCR; 32MM THD6.5X120 CANC SCR; due to packaging design verification test failure, 32MM THD Zimmer is recalling six types Aseptic packaging implants and devices in different packaging configurations. Specifically; when the device damaged the internal or external packaging tray or lost the integrity of the seal, multiple test samples from each of the six configurations failed to pass the simulated distribution and transportation tests.

August 26, 2014, Zimmer; Inc. Endo and unipolar femoral head – Endo and unipolar femoral head: Endo femoral head 43 mm diameter; Endo femoral head diameter 53 mm; Endo femoral head diameter 47 mm; Endo femoral head Diameter 50 mm; Endo femoral head diameter 42 mm; Endo femoral head diameter 54 mm; Endo femoral head diameter 48 mm; Endo femoral head diameter 41 mm; Endo femoral head diameter 42 mm; Endo femoral head diameter 43 mm; Endo femoral head diameter 44 mm; Endo femoral head diameter 45 mm; Endo femoral head diameter 46 mm; Endo femoral head diameter 47 mm; Endo femoral head diameter 48 mm; Endo femoral head diameter 49 mm; Endo femoral head diameter 50 mm; Endo femoral head diameter 51 Endo femoral head diameter 52 mm; Endo femoral head diameter 53 mm; Endo femoral head diameter 54 mm; ENDO femoral head 55 mm diameter Zimmer is recalling aseptic packaging in six different packaging configurations due to failed packaging design verification tests Implants and devices. Specifically; when the device damaged the internal or external packaging tray or lost the integrity of the seal, multiple test samples from each of the six configurations failed to pass the simulated distribution and transportation tests.

August 26, 2014 Curbell Medical; Inc. CareSense Monitor – CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor; Model # CSM-BC400; — Generic/Common Name: Hospital Bed Monitor; Classification Name: Hospital Bed Monitor — The monitor is connected to the sensor pad, and if the patient tries to get up from the bed, the sensor pad will monitor it; a chair; a floor mat; or a toilet seat. The monitor will sound an alarm. The company is aware of potential problems caused by customer complaints. After negotiating with the manufacturer; it was found that the resistor was incorrectly placed on the circuit board of the display. This change to the resistor is a planned change to address product improvements (improvement of battery consumption). However; this modification presents the monitor's alarm via t

August 26, 2014, Zimmer; Inc. Endo and unipolar femoral head-Endo and unipolar femoral head: ENDO FEMORAL HEAD 41MM DIAENDO FEMORAL HEAD 42MM DIAENDO FEMORAL HEAD 43MM DIAENDO FEMORAL HEAD 44MM DIAENDO FEMORAL HEAD 45MM HERALA 45MM HERALA 45MM HERALA HERALAENDO 45MM HERALADO 45MM HERALADO 45MM DIAMOND 45MM DIAMOND 42MM DIAENDO Femoral Head DIAENDO Femoral Head 50MM DIAENDO Femoral Head 51MM DIAENDO Femoral Head 52MM DIAENDO Femoral Head 53MM DIAENDO Femoral Head 54MM DIAENDO Femoral Head 55ENDO Femoral Head 54MM DIAENDO Femoral Head 55ENDO Femoral Head 57MM DIAENDO Femoral Head 63MM DIAENDO Femoral Head FEM HEAD 41MMENDO FEM HEAD 42MMENDO FEM HEAD 43MMENDO PROS HEAD 44MMENDO FEM head 45MMENDO FEM head 46MMENDO FEM head 47MMENDO FEM head 48MMENDO FEM head 49MMENDO FEM head 50MMENDO FEM head 51MMENDO FEM FEM head 52MMENDO FEM head Section 53MMENDO FEM HEAD 55MMENDO FEM HEAD 55MMENDO FEM HEAD 55MMENDO FEM HEAD 55MMENDO FEM HEAD 55MMENDO FEM HEAD 41MM unipolar assembly; 42MM unipolar assembly; 43MM unipolar assembly; 44MM unipolar assembly; 45MM unipolar assembly; 46MM unipolar assembly; 47MM Unipolar components; 48MM unipolar components; 49MM unipolar components; 50MM unipolar components; 51MM unipolar components; 52MM unipolar components; 53MM unipolar components; 54MM unipolar components; 55MM unipolar components; 56MM unipolar components; 57MM Unipolar components; 58MM unipolar components; 59MM unipolar components; 60MM Zimmer is recalling aseptic packaged implants and devices in six different packaging configurations due to failed packaging design verification tests. Specifically; when the device damaged the internal or external packaging tray or lost the integrity of the seal, multiple test samples from each of the six configurations failed to pass the simulated distribution and transportation tests.

August 26, 2014, Zimmer; Company Trauma Tubing and Sheet-Trauma Tubing and Sheet: TUBE & SCP PLT 90DX150LGTUBE and SCP PLT 90DX205LGTUBE and SCP PLT 90DX255LGTUBE and SCP PLT 95DX150LGTUBE and SCP PLT 95DX205LGTUBE and SCP PLT 95DX255LGTUBE and SCP PLT 130DX8HTUBE and SCP PLT 130DX8HTUBE PLT 130DX10HTUBE and SCP PLT 130DX12HTUBE and SCP PLT 130DX14HTUBE and SCP PLT 135DX8HTUBE and SCP PLT 135DX10HTUBE and SCP PLT 135DX12HTUBE & SCP PLT 135DX14HTUBE & SCP PLT 140DX8HTUBE & SCP PLT 140DX10HTUBE & SCP PLT 140DX12HTUBE & SCP PLT 140DX14HTUBE & SCP PLT 145DX8HTUBE & SCP PLT 145DX10HTUBE & SCP PLT 145DX12HTUBE & SCP PLT 145DX14HTUBE & SCP PLT 150DX6HTUBE & SCP PLT 150DX8HTUBE & SCP PLT 150DX10HTUBE & SCP PLT 150DX12HTUBE & SCP PLT 150DX14HVERSA -FX II SC TUBE PLT 90DX6HVERSA-FX II SC TUBE PLT 90DX8HVERSA-FXII SC TUBE PLT 90DX10HVERSA -FXII SC95DXESSA-FXII SC95DXESSA-FXIIHVERSA-FXII tube PLT 95DX6HVERSA-FXII SC tube PLT 95DX10HVERSA-FXII SC95DXESSA-FXII 95DXKEYSHA5-DXESSA-FXL95DXKEYSA-FXL95-DX KEYSA-FXL95-XKEYSA-FXII TubePLT 90D X 11HOLEVERSA-FX Keyless 95D X 8HOLEVERSA-FX Keyless 95D X 11HOLEVERSA-FX Keyless 95D X 14HOLEVERSA-FX II STD TUBE 130DX8HVERSA-FX II STD TUBE 130DX10HVERSA-FX II STD DX112HD -FX1DDX1212FX21DX-TUBE1FXSA-FX1-DX1121FXS-FX-FX-FX-FX-12HD-DX-TUBE3 STD tube 135DX10HVERSA-FX II STD tube 135DX12HVERSA-FX II STD tube 135DX14HVERSA-FX II STD tube 140DX8HVERSA-FX II STD tube 140DX10HVERSA-FX II STD tube FX II STD TUBE-IIHD 140DXDFX-140HD tube STD tube 12DX-140FX-140DX-140DX 140DX 140DX-140-FX tube STD tube 145DX10HVERSA-FX II STD TUBE 145DX12HVERSA-FX II STD TUBE 145DX14HVERSA-FX II STD TUBE 150DX8HVERSA-FX II STD TUBE 150DX10HVERSA-FX II STD TUBE 150DX12HVERSA-FX II STD TUBE 150DX14HVERSA-FX II KEYLESS TB 130DX8HVERSA-FX II KEYLESS TB 135DX8HVERSA- FX II Keyless TB 140DX8HVERSA-FX II Keyless TB 145FX8HVERSA-FX II Keyless TB 145FX8HVERSA-FX II Keyless 90D X 8HOLEVERSA-FX Keyless 90D X 11HOLEVERSA-FX KEYLESS8HVERSA-FX KEYLESS15HVERSA-FX KEYLESS8HVERSA-FX KEYLESS89HVERSA-FX KEYLESS8HVERSA-FX KEYLESS89HVERSA-FX KEYLESS89HVERSA-FX KEYLESS89 The aseptic packaging kid failed the packaging design verification test and configured the packaged lights and instruments in six different packages. Specifically; when the device damaged the internal or external packaging tray or lost the integrity of the seal, multiple test samples from each of the six configurations failed to pass the simulated distribution and transportation tests.

August 26, 2014, Zimmer; Inc. Knee instrument fixation screws-Knee instrument fixation screws: 48MM HEADED SCREW 48MM HEADDLESS SCREWMIS HEADED SCREW; 48MMMIS headless screws; 48MM Zimmer is recalling due to the failure of the packaging design verification test Aseptic packaging implants and devices in six different packaging configurations. Specifically; when the device damaged the internal or external packaging tray or lost the integrity of the seal, multiple test samples from each of the six configurations failed to pass the simulated distribution and transportation tests.

August 26, 2014, Zimmer; Company Knee Rod Extension and Impact Sleeve-Knee Rod Extension and Impact Sleeve Length: STEM implant 20MMDX145MMSTEM implant 22MMDX145MMSTEM implant 24MMDX145MMSHARP groove ST 20MMDX75MMSHARP groove ST 22MMDX75MMSHARP FLTD ST 24MMDX75MMSHARP groove Groove ST 20MMDX130MMSHARP Groove ST 22MMDX130MMSHARP Groove ST 24MMDX130MMCEMENTED STEM EXT 13MM X 145MMIMPACTOR sleeve* NGK STEM EXT 12X245MM (200MM) NGK stem EXT 13X245MM (200MM) NGK stem EXT 14X245MM (200MM)NGK stem EXT 15X245 Stem EXT 16X245MM (2002MM00MM2000MM EXTNG) STEM70MM EXTNG 14X245MM (200MM)NGK Stem 20X245MM (200MM) NGK STEM EXT 22X245MM (200MM) SMOOTH REV STM 9.5MM X 19SMOOTH REV STM 11.5MM X 1SMOOTH REV STM 13.5MM X 13.5MM X 1SMOOTH REV STM 13.5MM X 13.5MM MM 100MM STM EMM X 100MM FEM10 STM 15.5MM X 19SMOOTH REV STM 12.5MM X 200MREV FEM STM 14.5MM X 200MREV FEM STM 16.5MM X 200M18.5X200MM REV STEMREV FEM STM 10.5MM X 250MREV FEM STM 12.5MM X 250MMX 250MREV5.5MMR X 200M18.5X200M X 200M18.5X200MMR FEM5MM1.FEM5MM1.FEM5MM1.5MM1.5MMR 5 times 155MM slotted eccentricity R16.5X155MM slotted eccentricity R18.5X155MM slotted eccentricity R20.5X155MM slotted eccentricity R12.5X175MM slotted rotation STMFLUTE REV STEM – 14.5MM XFLUTE REV STEM.XFLUTE REV REV STEM.XFLUTE REV STEM.XLUTE 165MMV16.5MMVLUF16 – 22.5MM XFLUTED REV STM 10.5MM X 1FLUTED REV STM 11.5MM X 1FLUTED REV STM 12.5MM X 1FLUTED REV STM 13.5MM X 1FLUTED REV STM 1FLUTED REV SLU 16.5 REV 15MM REV 16 is sterile. ZFLUTED REV 15MM REV 15MM Aseptic recall. -Implants and devices packaged in six different packaging configurations due to failed packaging design verification tests. Specifically; when the device damaged the internal or external packaging tray or lost the integrity of the seal, multiple test samples from each of the six configurations failed to pass the simulated distribution and transportation tests.

August 26, 2014 Siemens Medical Diagnostics; Inc. Siemens Dimension EXL Chemical System-Siemens Dimension EXL integrated chemical system in vitro diagnostic equipment, designed to measure various analytes in human body fluids. All serial numbers for material numbers: 10636929; 10636928; 10486890; 10472176; 10639337; and 10639338.         

August 27, 2014 Thermedx LLC Thermedx fluid management system-Thermedx fluid management system is designed to provide irrigation fluid for irrigation; expansion; debridement, while heating fluid to help prevent hypothermia during the perioperative period. The fluid is heated by an internal infrared mechanism. In addition, the system will house a suction tank for collecting used flushing fluid. The supplier changed the manufacturing process of the components used in the tank ring, which may affect the performance of the ring. When the liquid collection tank is full, the displayed shortage may be higher than the actual shortage.

On August 28, 2014, Cordis Corporation EMPIRA (TM) RX PTCA dilatation catheter-Cordis EMPIRA RX PTCA dilatation catheter Cordis Corporation and Creganna-Tactx Medical observed their products Cordis EMPIRA (trademark) NC RX PTCA dilatation catheter and Cordis balloon EMPIRA ( Trademark) RX PTCA dilatation catheter; covered with a hydrophilic coating; may exhibit resistance to removal of the balloon cap. Possible weakening of the affected product in the proximal balloon sealing area

On August 28, 2014, Cordis Corporation EMPIRA (TM) NC RX PTCA dilatation catheter – Cordis EMPIRA NC RX PTCA dilatation catheter Cordis Corporation and Creganna-Tactx Medical observed their products Cordis EMPIRA (trademark) NC RX PTCA dilatation catheter balloon and Cordis EMPIRA (trademark) RX PTCA dilatation catheter; covered with a hydrophilic coating; may show resistance to removal of the balloon cap. Possible weakening of the affected product in the proximal balloon sealing area

August 28, 2014 Civco Medical Instruments Inc CollectEVAC – CollectEVAC; sterile equipment with catheters and adapters for ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Receive only. Sterile EO. The product is intended for irrigation; tissue collection; and/or tension function during transurethral prostate or bladder surgery. Pinhole leaks found in the packaging of the recalled product may compromise the sterility of the product. August 29, 2014 OrthoPediatrics Corp Casing Installation Tool Instrument-ACL Casing Installation Tool Dimensions: 6mm; 6.5mm; 7.0mm; 7.5mm; 8.0mm; 8.5mm; 9.0mm; 10.0mm Product use: OrthoPediatrics ACL reconstruction The system is a ACL reconstruction system for pediatrics and small-sized adults, providing fixtures and instruments in one system. The insertion tool is used with a mallet to knock the tunnel sleeve implant into the countersunk hole in the bone. The weld on the ACL reconstruction system casing installation tool is broken.

Submit as follows: Food and Drug Administration (FDA), News Well, Recall, Regulatory/Compliance

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