Device Recall Customed

Product code 900-1062, 16 lots: 109071569 112072765 112083154 113057380 113057684 113057854 113078233 113078670 113089154 113099586 131110151 131110593 131210956 140412452 140513063 140513390

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

ARTHROSCOPY PACK- || (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF || (2) BANDAGE ELASTIC 6" X 5yrd. LIF || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT || (1) DURAPREP SURGICAL SOLUTION 26m I LIF || (1) STOCKINETIE IMPERVIOUS || (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF || (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF || (1) BAG SUTURE FLORAL LIF || (1) BLADE SURGICAL #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 STAND COVER REINFORCED LIF || (4) TOWELS ABSORBENT 15" X 20" LIF || (5) LAP SPONGES PRE-WASH XRD UF || (1) DRAPE SHEET 41 " x 58" SMS UF || (1) NEEDLE HYPODERMIC 22G X 1 Y:z || (1) NEEDLE HYPODERMIC 18G X 1 Y:z || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (10) GAUZE SPONGES 4" X 4" 16PL Y || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Product code 900-1091, 56 lots: 110020286 110030631 110040867 110051180 110071617 110081956 110092110 110092379 110112598 110123050 111010018 111020258 111020449 111030543 111051225 111051262 111061481 111071752 111071879 111082042 111092470 111102655 111112944 111112979 111123313 112010019 112020307 112030825 112041390 112041451 112051726 112062316 112072825 112083159 112083381 112093855 112124920 113015425 113025927 113026164 113036314 113047314 113057381 113057855 113078235 113078673 113099267 131110152 131110594 131210957 140111404 140211917 140312390 140412827 140513064 140513451

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

PERY GYN PACK- CUSTOMED- || (1) DRAPE ABDOMINAL WITH TAPE UF || (1) TOWEL ABSORBENT 15" X 20" UF || (2) LEGGINGS W/7" CUFF 30" X 42" || (1) TABLE COVER REINFORCED 44" X 78" UF || (1) DRAPE UNDERBUTTOCK WITH POUCH || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Product code 900-1127, 27 lots: 111082044 111092578 111102824 111112983 111123318 112020311 112030602 112041178 112072767 112083205 112093744 113015572 113025906 113036449 113047145 113068141 113088830 113099339 131110626 131210624 140111138 140211532 140211883 140412442 140412828 140513066 140513253

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

FOLEY CATHETER KIT 1116FR. - CUSTOM ED- || (1) WRAPPER 24" X 24" || (1) PVP TRIPLE SWABSTICK IODOPHOR || (2) GLOVE MED FREETOUCH VYNIL P/F || (1) JELLY LUBRICATING 5 GRAM || (1) TOWEL 3PLY POLY 17" X 18" || (2) SWABSTICK DRY COTTON || (1) DRAPE 4" FENESTRATED 18" X 26" || (1) CATHETER 16FR. FOLEY, 2 WAY,5cc, Silicone Coated || (1) SYRINGE 10cc WATERPREFIL UF || (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF || (1) LABEL ID PATIENT || (1) TRAY ORGANIZER || (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Product code 900-1139, 13 lots: 111112985 111123474 112010023 112041179 112072768 112083208 112093742 112103742 112114377 113015573 113109708 140211533 140412580

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

FOLEY CATHETER KIT 1118FR.- CUSTOM ED || CONTENTS: || (1) WRAPPER 24" X 24" || (1) LABEL ID PATIENT || (1) TRAY ORGANIZER || (1) PVP TRIPLE SWABSTICK IODOPHOR || (2) GLOVE MED FREETOUCH VYNIL P/F || (1) JELLY LUBRICATING 5 GRAM || (1) TOWEL 3PL Y POLY 17" X 18" || (2) SWABSTICK DRY COTTON || (1) DRAPE 4" FENESTRATED 18" X 26" || (1) CATHETER FOLEY 18FR, 2WAY SILICONE COATED || m SYRINGE 10ccWATERPREFIL UF || (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF || (1)SPECIMEN CONTAINER 4oz W/LID & LABEL || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Product code 900-1146, 36 lots: 109051127 110040868 110051198 110092116 110092352 110102423 111010024 111030547 111051146 111061483 111082046 111092345 111102659 111112945 111123320 112010025 112010277 112020314 112041069 112051672 112082330 112083209 112093735 112124923 113015489 113015687 113026040 113026202 113078237 131110156 131210626 140111140 140111777 140412582 140513068 140513475

Neurological Devices

1

No

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

NEURO PACK - || (1) CAUTERY TIP POLISHER LIF || (4) DRAPE UTILITY WITH TAPE LIF || (1) INSTRUMENT POUCH || (10) LAP SPONGE PRE-WASH XRD || (1) Pk. SURGICAL STRIP W' X 6" || (2) UTILITY BOWL 32oz || (1) MAYO TRAY LARGE || (9) SHEET DRAPE 41 " X 69" MEDIUM LIF || (1) NEEDLE HYPODERMIC 18G X 1 LIF || (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL || (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) SHEET MINOR LAP 102" X 121" X 78" || (1) SAFETY SCALPEL #10 || (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF || (4) CLOTH HUCK TOWELS BLUE || (1) PENCIL CAUTERY ROCKER SWITCH || (2) LEGGINS W/7'' CUFF 30" X 42" || (1) DRAPE% ECONOMY 53" X 77" LIF || (1) Pk. SURGICAL STRIP 'X" X 6" || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F || (2) ROUND WASH BASIN 6QT || (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE || (2) Pr. SURGICAL GLOVES 7 || (1) SKIN MARKER WITH RULER LIF || (1) Pk. STERI STRIP CLOSURE %"X 4" LIF || (1) TUBE SUCTION CONNECT. 'X" X 12' LIF || (1) SAFETY SCALPEL #15 || (1) SAFETY SCALPEL #11L/F || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.