BEUDAMED
    FDA Enforcement Class II Terminated

    Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022

    Recall: Z-2547-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2547-2015
    Event ID
    71963
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    August 19, 2015
    Classification Date
    September 2, 2015
    Termination Date
    May 24, 2017
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022

    Reason

    Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns

    Code Info

    Lot Numbers: 516907, 519815, 519816

    Distribution

    Nationwide Foreign: Canada Australia Denmark Germany New Zealand

    Quantity

    56,000 sets