Device product
CESAREAN PACK- (1) BEANNIES BABY LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (3) SHEET DRAPE 41 " X 58" SMS LIF (5) TOWEL ABSORBENT 15" X 20" LIF (15) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR LIF (2) PAD OBSTETRICAL X-LARGE LIF (1) SYRINGE EAR/ULCER 2oz. L/F (1) BLANKET 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 W/LID PLASTIC 80oz. (1) UMBILICAL CORD CLAMP (1) TUBE FEEDING PVC 8FR 15" LONG (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (1) BAG SUTURE FLORAL (2) GLOVE MEDIUM FREETOUCH VYNIL POWDER FREE (1) SCALPEL W/HANDLE #1 0 (1) SCALPEL W/HANDLE #20 (2) BOWL UTILITY 16oz. LIF (1) PVP PAINT 8" STICK SPONGE LIF (1) GOWN SURG REINFORCED X-LARGE TOWEL/ WRAP LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) SCISSOR UMBILICAL 4.5" STRAIGHT (1) WRAPPER 24" X 24" LIF (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 LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2354-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 19 lots; 968 units (multiple units per lot)
- Official record key
device-enforcement:Z-2354-2014
Official wording
Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Code information: Product code 900-851, 19 lots: 112093954 112114401 112125118 113015517 113046987 113047162 113057510 113067939 113078349 113088895 113099457 113109877 131110317 140111098 140211857 140312187 140412474 140513147 140513483
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
packaging integrity may be compromised
-
Sterility assurance
loss of sterility