BEUDAMED
    FDA Recall Terminated

    Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY. The Snare Kit contains a pouch labeled a "Snare Catheter" and a pouch labeled "Amplatz Goose Neck Snare". Snare Catheter

    Recall: Z-0992-2007 · Initiated May 18, 2007

    Recall

    Recall Number
    Z-0992-2007
    Event Number
    38052
    FEI Number
    2183870
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 18, 2007
    Posted
    July 11, 2007
    Terminated
    October 17, 2008
    Address
    Ev3 Inc 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY. The Snare Kit contains a pouch labeled a "Snare Catheter" and a pouch labeled "Amplatz Goose Neck Snare". Snare Catheter

    Reason

    Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr.

    Action

    Letter May 18, 2007.

    Distribution

    Worldwide, including USA, Belgium, France, Germany, Italy, Jordan, Spain, United Kingdom, and Yemen.

    Quantity

    23 units