BEUDAMED
    FDA Recall Terminated

    life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium Sulfur Dioxide, OEM P/N: 9146-001, voltage 12V, 7.5 amps, Mfg for Battery Zone, Inc ; Mfg by Nordix, Inc.

    Recall: Z-0523-2008 · Initiated August 24, 2007

    Recall

    Recall Number
    Z-0523-2008
    Event Number
    45814
    Firm
    BatteryZone, Inc.
    FEI Number
    3006525760
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    August 24, 2007
    Posted
    December 22, 2007
    Terminated
    July 1, 2013
    Address
    14 Culnen Dr, Branchburg, NJ, 08876-5400

    Description

    life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium Sulfur Dioxide, OEM P/N: 9146-001, voltage 12V, 7.5 amps, Mfg for Battery Zone, Inc ; Mfg by Nordix, Inc.

    Reason

    Marketed without 510 (K) approval

    Action

    The original recall communication (important recall information) was sent out on 9/3/07 by Phoenix Solutions, a consultant to Battery Zone. A second recall communication, Urgent Device Recall, was issued by Battery Zone dated 10/25, and was sent out to all customers (even those who had returned product) on 11/5/07. Both communications were sent by first class mail.

    Distribution

    Nationwide; (primarily police/fire departments)

    Quantity

    24 units