BEUDAMED
    FDA Enforcement Class I Terminated

    BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4" X 4" 12PLY (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WIT APE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    Recall: Z-2417-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2417-2014
    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

    BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4" X 4" 12PLY (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WIT APE 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 900-1880, 1 lots: 109010222

    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

    1 lot; 40 units (multiple units per lot)