BEUDAMED
    FDA Recall Terminated

    AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN

    Recall: Z-0703-2007 · Initiated February 19, 2007

    Recall

    Recall Number
    Z-0703-2007
    Event Number
    37615
    Firm
    American Medical Systems
    FEI Number
    1000116179
    Product Code
    FAE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 19, 2007
    Posted
    April 3, 2007
    Terminated
    June 27, 2007
    Address
    10700 Bren Rd, W Minnetonka, MN, 55343-9679

    Description

    AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN

    Reason

    Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.

    Action

    The consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems.

    Distribution

    Nationwide

    Quantity

    5 devices