BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-2391-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2391-2014
    Event ID
    68536
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Customed, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2014
    Initiation Date
    May 20, 2014
    Classification Date
    August 29, 2014
    Termination Date
    August 14, 2017
    Address
    Calle Igualdad Final #7, Fajardo, PR, 00738, United States

    Description

    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.

    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 Info

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

    Distribution

    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.

    Quantity

    14 lots; 295 units (multiple units per lot)