Device product
ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd. UF (1) IMPERVIOUS STOCKINETTE 14" X 48" (1) HUCK CLOTH TOWEL WHITE (1) MAYO STAND COVER REINFORCED LIF (1) U DRAPE 60" X70" WITH TAPE SPLIT (4) STRIPS TAPE 24" X 4" L/F (1) STOCKINETTE 6" X 48" LIF (1) MAYO TRAY SMALL (5) HUCK CLOTH TOWELS BLUE (2) UTILITY BOWL 32oz (2) GOWN SURGICAL REINFORCED X-LARGE LEVEL IV (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) SHEET EXTREMITY ABS. 125" x 85" SMS (5) LAP SPONGE PREWASH XRD (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) PENCIL CAUTERY ROCKER SWITCH (1) SKIN MARKER INK WITH 8 LABEL (2) LITES GLOVES UF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CAUTERY TIP POLISHER UF (4) DRAPE UTILITY WITH TAPE UF (1) BAG BIOHAZARD 30" X 37" (1) BAG SUTURE FLORAL (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2356-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 11 lots; 273 units (multiple units per lot)
- Official record key
device-enforcement:Z-2356-2014
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 900-902, 11 lots: 112041360 112051755 112052021 113015521 113025983 113036389 113067942 113078352 140312189 140412917 140513342
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