BEUDAMED
    FDA Recall 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 · Initiated May 2, 2011

    Recall

    Recall Number
    Z-1645-2013
    Event Number
    65423
    Firm
    BRAEMAR, INC.
    FEI Number
    1000520785
    Product Code
    DRG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 2, 2011
    Posted
    July 2, 2013
    Terminated
    July 15, 2013
    Address
    1285 Corporate Center Dr, Eagan, MN, 55121-1267

    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.

    Action

    Braemar began notifying customers by telephone on 5/2/2011. Braemar issued Advisory Notice letter P/N 600-0662-00 RevA dated May 16, 2011. The letter was sent by UPS to all consignees.The letter described the problem and the product involved in the recall. Consignees were advised not to use the battery pack in the Braemar ER920W or Braemar Fusion device and requested consignees to complete and return the Verification Form. For questions regarding this recall call 651-286-8620.

    Distribution

    Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.

    Quantity

    10,785 packs