Recall record at a glance
| Official record | Z-2354-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Customed, Inc. |
| Report date | Sep 10, 2014 |
| Recall initiation date | May 20, 2014 |
| Quantity | 19 lots; 968 units (multiple units per lot) |
| Location | Fajardo, PR, United States |
Official product description
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.
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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