Device product
PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill (1) DRAPE UNDERBUTIOCK W/POUCH 44" X 35" (1) TIME OUT BEACON NON WOVEN (1) BOWL UTILITY BLUE 16oz (1) BAG SUTURE FLORAL (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) GOWN IMPERV. EXTRA REINF LGE AAMI LEVEL Ill T/WRAP (1) CATHETER 16" 18FR MALE PVC (2) LEGGINS W/7'' CUFF 30" X 44" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Z-2332-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2 lots; 48 units (multiple units per lot)
- Official record key
device-enforcement:Z-2332-2014
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 900-548A, 2 lots: 140312022 140412694
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