BEUDAMED
    FDA Enforcement Class II Terminated

    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

    Recall: Z-1652-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1652-2013
    Event ID
    65410
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BRAEMAR, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 10, 2013
    Initiation Date
    February 24, 2012
    Classification Date
    July 2, 2013
    Termination Date
    July 15, 2013
    Address
    1285 Corporate Center Dr, N/A, Eagan, MN, 55121-1267, United States

    Description

    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

    Reason

    Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact.

    Code Info

    n/a

    Distribution

    Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.

    Quantity

    3286 packs