Device product
LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP (1) BLADE SURGICAL #11 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN XLARGE SMS IMPERV. REINFORCED (3) TOWEL ABSORBENT 15" X 20" UF (1) TUBBING INSUFFLATION SET WITHOUT RING (1) MAYO STAND COVER REINFORCED UF (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) SKIN MARKER INKW/8LABEUTIME OUT/RULER (1) DRAPE SHEET 41 " X 58" SMS UF (1) BAG SUTURE FLORAL (4) DRAPE UTILITY UF (1) TUR CYSTO IRRIGATION SET 79" SINGLE UF (1) TUBE SUCTION CONNECT. 3/16 " x 12' UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2334-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2 lots; 40 units (multiple units per lot)
- Official record key
device-enforcement:Z-2334-2014
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 900-576A, 2 lots: 140312024 140513373
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