BEUDAMED
    FDA Enforcement Class II Terminated

    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

    Recall: Z-1645-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1645-2013
    Event ID
    65423
    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
    May 2, 2011
    Classification Date
    July 1, 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 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

    Reason

    Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. 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, MD, MN, NY, OH, PA, SC, TN, and TX.

    Quantity

    10,785 packs