Device product
Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION TUBE W/0 VENT LIF (2) COUNTER NDL /BLADE IOc MAG/CLEAR ( I) GOWN XL SMS IMPERV. REINFORCED LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF ( I) GOWN SURG REINFORCED. LGE T/WRAP LIF ( I) TUBE SUCTION CONNECT W' X 12' LIF (2) LITE GLOVE LIF ( 10) GAUZE SPONGE4" X 4" 16PLY XRD LIF (2) DRAPE SHEET 41" X 58" SMS LIF ( I) CAUTERY TIP POLISHER LIF ( I) MERLING SKIN PREP APPLIC. 39ML LIF ( I) UTILITY BOWL PINT 16oz LIF ( I) SKIN STAPLE 35 WIDE LIF ( I) UTILITY BOWL QUART 32oz LIF ( I) BLADE SURGICAL II CARBON STEEL ( I) TRAY MAYO SMALL ( I) BLADE SURGICAL 20 CARBON STEEL ( I) MAYO STAND COVER REINFORCED LIF ( I) DRAPE LAPAROTOMY 100" X 72" X 124" W/POUCH Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2476-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2 lots, 93 units, multiple packed units per lot
- Official record key
device-enforcement:Z-2476-2014
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 900-2516, 2 lots: 131110250 131210792
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