Device product
O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF ( I) VAGINAL PACKING SPONGEXRD ( I) BOWL WITH LID PLASTIC 80oz ( I) RECEIVING BLANKET 100% COTTON (I) BABY BLANKET POLY ABSORBENT IMPERVIOUS (I) CORD UMBILICAL CLAMP (4) TOWELS ABSORBENT 15" x 20" LIF ( I) UTILITY BOWL 16oz. (2) TRAY ORGANIZER FULL DEEP (3) T IP ABSORBENT APPLICATOR (2) GLOVES EXAM MEDIUM (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (10) GAUZE SPONGE 4" X 4" 12PLY (2) PAD OBSTETRJCAL X-LARGE ST. (I) EAR ULCER SYRINGE 2oz. LIF (I) BABY BEANNIES (2) SHEET DRAPE 4 1" x 58" SMS LIF (I) SCISSORS UMBILICAL (I) TABLE COVER REINFORCED 50" x 90" LIF (2) WRAPPER 24" X 24" L/f Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2427-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 23 lots; 1396 units (multiple units per lot)
- Official record key
device-enforcement:Z-2427-2014
Official wording
Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on differ 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 900-2002, 23 lots: 111113064 111123196 111123470 112010109 112041220 112051915 112062471 112083419 112093922 112104298 112114657 112125310 113015054 113015437 113067910 113088778 113089204 113099408 131110220 140111321 140211502 140211932 140312439
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