BEUDAMED
    FDA Recall Terminated

    1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 unit per pouch/30 per box); Cat No 1680-003 (3 units per pouch/30 per box); Cat No 1680-005 (5 units per pouch/50 per box); and Cat No 1680-030 (30 units per pouch/no box). The electrodes are packaged 600 units/case. Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York

    Recall: Z-1184-03 · Initiated July 30, 2003

    Recall

    Recall Number
    Z-1184-03
    Event Number
    26988
    Firm
    Conmed Corporation
    FEI Number
    3001451571
    Product Code
    DRX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 30, 2003
    Posted
    August 27, 2003
    Terminated
    March 21, 2005
    Address
    525 French Road, Utica, NY, 13502

    Description

    1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 unit per pouch/30 per box); Cat No 1680-003 (3 units per pouch/30 per box); Cat No 1680-005 (5 units per pouch/50 per box); and Cat No 1680-030 (30 units per pouch/no box). The electrodes are packaged 600 units/case. Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York

    Reason

    Separation of the sensing element from the body of the electrode.

    Action

    Letters dated 7/30/03 requesting return of recalled lots and subrecall by distributors.

    Distribution

    241 direct accounts including wholesalers and medical facilities. Of these, there are 15 foreign consignees in Canada, Belgium, Germany, Norway, The Netherlands, Spain, United Kingdom, Japan, Malaysia, Thailand, and United Arab Emirates .

    Quantity

    200,412 electrodes (# corrected 9/5/03)