BEUDAMED
    FDA Enforcement Class I Terminated

    CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.

    Recall: Z-0461-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0461-2015
    Event ID
    69752
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConMed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    November 6, 2014
    Classification Date
    December 4, 2014
    Termination Date
    October 30, 2017
    Address
    525 French Rd, N/A, Utica, NY, 13502-5945, United States

    Description

    CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.

    Reason

    Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.

    Code Info

    All Lot Codes

    Distribution

    Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.

    Quantity

    174,610 (168,090 US and 6,520 OUS) in total.