BEUDAMED
    FDA Recall Terminated

    Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081

    Recall: Z-0924-04 · Initiated April 28, 2004

    Recall

    Recall Number
    Z-0924-04
    Event Number
    28951
    Firm
    Medtronic Gastroenterology Urology
    FEI Number
    1000135098
    Product Code
    FFX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2004
    Posted
    July 20, 2004
    Terminated
    November 21, 2005
    Address
    4000 Lexington Ave N, Shoreview, MN, 55126-2917

    Description

    Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081

    Reason

    Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.

    Action

    Letters dated April 28, 2004 were sent to the consignees. Enclosed with the letter to each consignee were replacement power cord(s). The letters instruct consignees to replace the current power cord by following instructions enclosed with the letter.

    Distribution

    The devices were distributed nationwide in the United States.

    Quantity

    42 units