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Recall Observatory FDA recall evidence

Device product

PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90" (1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44" X 26" LIF (30) COTION TIP APPLIC 6" WOOD LIF (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 20C FOAM I MAG L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Z-2391-2014

May 20, 2014

Class I

Product summary

Firm
Customed, Inc
Event
Event 68536
Status
Terminated
Classification
Class I
Quantity
14 lots; 295 units (multiple units per lot)
Official record key
device-enforcement:Z-2391-2014

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 900-1402, 14 lots: 112041394 112051751 112072866 112093870 112124944 113036451 113046933 113057834 113088696 113088831 131110172 140111093 140412599 140513083

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

    reason.labeling_packaging · v1.0.0

    packaging integrity may be compromised
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    loss of sterility