Device product
LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF (1) LITE GLOVE LIF (1) BAG SUTURE FLORAL (1) BLADE SURGICAL #1 0 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CAUTERY TIP POLISHER LIF (1) BAG GLASSINE (1) TABLE COVER 44" X 90" L/F (2) DRAPE SHEET 41 " X 58" SMS (1) LAPAROTOMY DRAPE "T" 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) TUBE SUCTION CONECT W' X 12' LIF (3) ABSORBENT TOWELS 15" X 20" LIF (1) CAUTERY PENCIL PUSH BOTTON (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP LEVEL Ill (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2364-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 34 lots; 3603 units (multiple units per lot)
- Official record key
device-enforcement:Z-2364-2014
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 900-996, 34 lots: 111040982 111051305 111061694 111071947 111082120 111092410 111092465 111102789 111113147 111123308 112010213 112020496 112030757 112041365 112052027 112072880 112083444 112093958 112114585 112125124 113025974 113036393 113057517 113057612 113057822 113078480 113078577 113099300 113099581 131110081 131110607 140111262 140211738 140513485
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