BEUDAMED
    FDA Recall Terminated

    Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring

    Recall: Z-1431-2010 · Initiated March 11, 2010

    Recall

    Recall Number
    Z-1431-2010
    Event Number
    54975
    Firm
    ConvaTec
    FEI Number
    3011987967
    Product Code
    DRX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 11, 2010
    Posted
    April 22, 2010
    Terminated
    June 21, 2011
    Address
    200 Headquarters Park Dr, Skillman, NJ, 08558

    Description

    Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring

    Reason

    In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.

    Action

    The one distributor was notified personally on March 9, 2010. All remaining stock was put on hold, and a "URGENT : MEDICAL DEVICE RECALL" letter dated March 11, 2010, was sent to customers. The letter describes the product, problem and action to be taken by customers. All customers were asked to immediately stop distributing and quarantine all recalled lots. The customers were ask to perform a count of recalled product currently in inventory, complete and return the Recall Response Form even if no recalled product is in inventory, send a copy of response to distributor in order to receive reimbursement, and to call 1-800-582-6514 for instructions on how to return the recalled product. If you have any questions, please contact Convatec at 908-904-2425.

    Distribution

    Nationwide distribution: CA

    Quantity

    567,000 units