BEUDAMED
    FDA Recall Terminated

    Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.

    Recall: Z-1236-03 · Initiated October 24, 2000

    Recall

    Recall Number
    Z-1236-03
    Event Number
    26245
    Firm
    GE Medical Systems Information Technologies
    FEI Number
    1030184
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 24, 2000
    Posted
    September 17, 2003
    Terminated
    June 6, 2008
    Address
    4502 Woodland Corporate Blvd., Tampa, FL, 33614

    Description

    Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.

    Reason

    Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.

    Action

    A Recall notification letter was mailed to all direct accounts on 10/24/2000 followed by a telephone call to each direct account. Distributors were not requested to subrecall because Critikon already knew the hospital accounts that had recieved product and they were notified via the 10/24/00 letter and phone call. Accounts were told to return product to Critikon for replacement.

    Distribution

    Product was distributed to the firm''s related warehouse in Texas and then on to 20 distributors and 8 hospitals in the United States and also one international distributor in Japan.

    Quantity

    235