BEUDAMED
    FDA Recall Terminated

    LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223

    Recall: Z-0546-2007 · Initiated January 10, 2007

    Recall

    Recall Number
    Z-0546-2007
    Event Number
    37252
    Firm
    GMP Companies/Lifesync Corporation
    FEI Number
    1000403400
    Product Code
    DRG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 10, 2007
    Posted
    February 27, 2007
    Terminated
    July 27, 2009
    Address
    One E. Broward Blvd., Suite 1701, Ft Lauderdale, FL, 33301

    Description

    LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223

    Reason

    When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation.

    Action

    The recall was initiated on January 15, 2007. The firm''s representatives, hand carried, Device Recall Letter to Account Representative and Risk Manager. Distributors who received the Device Recall Letter, purged their stock of the affected devices and notified their customers. Recall Communication was hand carried to each account with 100% compliance by LifeSync Clinical/Sales Personnel. EFFECTIVENESS CHECKS of this recall will be achieved through Return Material Authorization via telephone with each affected account.

    Distribution

    Nationwide

    Quantity

    272 cases