BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2547-2015 · Initiated August 19, 2015

    Recall

    Recall Number
    Z-2547-2015
    Event Number
    71963
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 19, 2015
    Posted
    September 2, 2015
    Terminated
    May 24, 2017
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    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

    Action

    Medtonic/Covidien issued recall letter on August 19, 2015. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 2 Ludlow Park Drive, Chicopee, MA 01022, Attention: Field Action Returns. Contact your Medtronic representative or Customer Service at (800)-882-5878.

    Distribution

    Nationwide Foreign: Canada Australia Denmark Germany New Zealand

    Quantity

    56,000 sets