BEUDAMED
    FDA Enforcement Class I Terminated

    Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A

    Recall: Z-0048-2015 · Reported October 22, 2014

    Enforcement

    Recall Number
    Z-0048-2015
    Event ID
    69257
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2014
    Initiation Date
    September 18, 2014
    Classification Date
    October 16, 2014
    Termination Date
    May 24, 2017
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A

    Reason

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

    Code Info

    Al lot codes

    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

    151,210 pairs