Device product
LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 41 II X 58" SMS L/F ( 1) TABLE COVER 50" X 90" LIF ( 1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) BLADE SURGICAL# 10 CARBON STEEL (5) LAP SPONGE PREWASH 18" X 18' XRD LIF (6) TOWELS ABSORBENT 15" X 20" LIF ( 1) CAUTERY TIP POLISHER L/F (2) UTILITY BOWL 16oz LIF (1) TUBE SUCTION CONNECT%" X 12' LIF (2) NEEDLE & BLADE COUNTER 10c MAG /CLEAR LIF (1) DRAPE T LAPAROTOMY 102" X 78" 121" SMS STD LIF ( 1) SPECIMEN CONTAINER 4oz WITH LID & LABEL ( 1) YANKAUER SUCTION TUBE WITHOUT VENT LIF ( 1) TIME OUT BEACON NON WOVEN LIF ( 1) GOWN SURG. REINFORCED XLGE TOWEL & WRAP LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2353-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 23 lots; 1966 units (multiple units per lot)
- Official record key
device-enforcement:Z-2353-2014
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 900-848, 23 lots: 112041259 112072813 112072916 112114685 112124855 112125308 113015569 113047034 113047207 113057642 113067938 113068189 113078590 113099301 113109648 113109876 131110346 140111253 140211856 140312186 140412473 140513146 140513482
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