BEUDAMED
    FDA Recall Terminated

    AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments.

    Recall: Z-0127-06 · Initiated September 1, 2005

    Recall

    Recall Number
    Z-0127-06
    Event Number
    33323
    Firm
    AGA Medical Corporation
    FEI Number
    3005334138
    Product Code
    KRD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 1, 2005
    Posted
    November 5, 2005
    Terminated
    November 13, 2006
    Address
    682 Mendelssohn Ave N, Golden Valley, MN, 55427-4306

    Description

    AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments.

    Reason

    Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed.

    Action

    Urgent Recall letters, dated 09/01/05, were sent to affected customers via email, facsimile and with follow-up delivery via USPS. OUS customers were notified via Federal Express. The letter described the situation, the lots being recalled and included a response form that was to be faxed back to AGA Medical.

    Distribution

    OUS countries include: Australia, Germany, Italy, Korea, Malasia, Slovakia, Spain, Switzerland, Thailand, United Kingdom

    Quantity

    81