BEUDAMED
    FDA Enforcement Class II Terminated

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    Recall: Z-1177-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1177-2018
    Event ID
    79337
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConMed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    February 23, 2018
    Classification Date
    March 24, 2018
    Termination Date
    September 17, 2020
    Address
    525 French Rd, Utica, NY, 13502-5945, United States

    Description

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    Reason

    Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure

    Code Info

    Lot Numbers: Y013114-14 Y04191607 Y061413-09 Y081513-07 Y101212-03 Y020714-08 Y04201507 Y06151504 Y081712-39 Y101413-12 Y021413-09 Y042514-10 Y061914-14 Y082212-13 Y10231528 Y021712-01 Y042712-06 Y06261516 Y08281506 Y10231529 Y030113-12 Y05041703 Y071213-13 Y090313-12 Y110714-08 Y03041604 Y05081508 Y071814-11 Y091914-13 Y112414-04 Y031414-04 Y051414-07 Y07191604 Y09241503 Y112613-03 Y032513-03 Y052914-08 Y072712-03 Y092612-16 Y112912-13 Y032612-05 Y060412-05 Y07271508 Y100212-01 Y11301601 Y040314-07 Y060713-12 Y080113-05 Y100713-02 Y121714-09 Y040813-01 Y06071704 Y081114-05 Y10071602 Y121813-09 Y041712-02

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).

    Quantity

    18,720 units in total