BEUDAMED
    FDA Recall Terminated

    Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.

    Recall: Z-1332-04 · Initiated July 27, 2004

    Recall

    Recall Number
    Z-1332-04
    Event Number
    29687
    Firm
    Advanced Bionics Corporation
    FEI Number
    1000220815
    Product Code
    MCM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 27, 2004
    Posted
    August 10, 2004
    Terminated
    March 23, 2012
    Address
    12740 San Fernando Rd, Sylmar, CA, 91342-3728

    Description

    Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.

    Reason

    Battery pack may overheat and cause patient burns.

    Action

    Notification letters were sent to all users and affiliates on July 27, 2004. Initially customers were informed that they will receive a retrofit kit. Firm decided to actually recall the battery packs and sent recall letters on August 10, 2004. All Auria Battery Packs are to be returned per instructions in the recall letters. Firm rerecalled powerpaks that had been repaired since FDA review has found that repairs are not sufficent to address all potential adverse events concieveable. The latest recall letter was sent May 11-12, 2005

    Distribution

    Nationwide and Canada

    Quantity

    2458