Device product
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 REINFORCED 50" X 90" (1) BAG SUTURE FLORAL (1) STOCKINETTE IMPERVIOUS 14" X 48" (4) STRIPS TAPE 24" X 4" (1) SHEET EXTREMITY ABS. 125" X 85" (1) TIME OUT BEACON NON WOVEN ST. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2363-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 11 lots; 540 units (multiple units per lot)
- Official record key
device-enforcement:Z-2363-2014
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 900-982, 11 lots: 112093957 112114688 112125123 113025981 113067944 113078479 113088900 113109884 131110285 140111261 140412707
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