BEUDAMED
    FDA Recall Terminated

    life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.

    Recall: Z-0521-2008 · Initiated September 3, 2007

    Recall

    Recall Number
    Z-0521-2008
    Event Number
    45819
    Firm
    Exocomm Tech Grp
    FEI Number
    3005689346
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    September 3, 2007
    Posted
    January 26, 2008
    Terminated
    July 1, 2013
    Address
    1874 Catasauqua Rd, Allentown, PA, 18109-3128

    Description

    life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.

    Reason

    Marketed without a 510K

    Action

    The original recall communication was sent out on 9/3/07 by Phoenix Solutions, a consultant to Battery Zone, as a Dear Valued Customer notice. A second recall communication, Urgent Device Recall Letter, was issued by Exxocom Technology Group dated 10/25, was sent out to all customer (even those who had returned product) on 11/5/07. Both communication were sent by first class mail, requesting return of batteries

    Distribution

    Worldwide-Batteries were distributed to dealers or distributors in CT, GA, MN, NC, NY, OH, OK, OR, PA and TN plus one Canadian Consignee

    Quantity

    46 units