BEUDAMED
    FDA Recall Terminated

    ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)

    Recall: Z-0064-04 · Initiated October 2, 2003

    Recall

    Recall Number
    Z-0064-04
    Event Number
    27388
    Firm
    Acist Medical Systems
    FEI Number
    3001726808
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 2, 2003
    Posted
    October 24, 2003
    Terminated
    November 23, 2005
    Address
    7450 Flying Cloud Dr., Suite 150, Eden Prairie, MN, 55344

    Description

    ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)

    Reason

    Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.

    Action

    The consignees were sent letters dated 10/2/03 which requested that the product be returned.

    Distribution

    Nationwide in the United States.

    Quantity

    7120 kits