BEUDAMED
    FDA Recall Terminated

    Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006

    Recall: Z-0046-2015 · Initiated September 18, 2014

    Recall

    Recall Number
    Z-0046-2015
    Event Number
    69257
    Firm
    Covidien LLC
    FEI Number
    1282497
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 18, 2014
    Posted
    October 15, 2014
    Terminated
    May 24, 2017
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006

    Reason

    Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs

    Action

    Covidien notified customers by letter via Federal Express on 9/18/14. The letter requests that they immediately verify that they are not stocking Covidien electrodes for use with Philips FR3 or FRx AED units. A customer reply acknowledgement form is provided to allow Covidien to track the effectiveness of the notification. Covidien is adding a label to all levels of packaging that alerts the user that the product is not compatible with the FR3 and FRx AED units. Distribution partners notified to address product in the distribution chain that is available to be relabeled. For questions customers should call (800) 962-9888, option 8, then extension 2500. For questions regarding this recall call 508-261-8000.

    Distribution

    Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.

    Quantity

    133,930 pairs