BEUDAMED
    FDA Recall Terminated

    Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

    Recall: Z-1184-2013 · Initiated April 8, 2013

    Recall

    Recall Number
    Z-1184-2013
    Event Number
    64868
    Firm
    Covidien LLC
    FEI Number
    1282497
    Product Code
    DRO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 8, 2013
    Posted
    April 29, 2013
    Terminated
    November 19, 2015
    Address
    15 Hampshire Street, Mansfield, MA, 02048-1113

    Description

    Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

    Reason

    Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient

    Action

    Covidien sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 8, 2013 to all affected customers. The letter identifies the product, problem and requests that customers immediately stop using and segregate any affected product from inventory. Questions:Call 1-800-962-9888 option 8, then extension 2500.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.

    Quantity

    133470 (sets of 2)