Device product
UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT. (1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN (1) BAG URINARY DRAINGAGE 2000ml ANTI-REFLUX (1) BAG SUTURE FLORAL (1) GOWN SURG. REINFORCED X-LARGE T/VIJRAP (1) TABLE COVER 44" X 90" UF (2) DRAPE SHEET 42" X 55" SMS UF (1) TUBE SUCTION CONNECT. Y." X 12' UF (1) MAYO STAND COVER REINFORCED UF (10) GAUZE SPONGE 4" X 4" 16PLY (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) TUR Y SET TWO LEAD ST. UF (1) DRAPE LITHO 110" X 63" SMS WITH LEGGINS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2411-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14 lots; 325 units (multiple units per lot)
- Official record key
device-enforcement:Z-2411-2014
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 900-1742, 14 lots: 111113032 111123382 112010089 112020407 112041202 112051876 112083407 112093915 112125157 113015435 113036757 140412562 140513111 140513393
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