BEUDAMED
    FDA Recall Terminated

    ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the TissueLink Bipolar Floating Device

    Recall: Z-1416-04 · Initiated July 22, 2004

    Recall

    Recall Number
    Z-1416-04
    Event Number
    29697
    FEI Number
    1000517638
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 22, 2004
    Posted
    September 1, 2004
    Terminated
    October 4, 2004
    Address
    TissueLink Medical, Inc. One Washington Center Suite 400, Dover, NH, 03820

    Description

    ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the TissueLink Bipolar Floating Device

    Reason

    Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.

    Action

    TissueLink notified the sales force on 7/22/04 to visit each account and retreive product at the hospital level.

    Distribution

    Nationwide

    Quantity

    96 units