BEUDAMED
    FDA Recall Terminated

    GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm

    Recall: Z-1236-06 · Initiated April 28, 2006

    Recall

    Recall Number
    Z-1236-06
    Event Number
    35507
    Firm
    W L Gore & Assoc, Inc.
    FEI Number
    2017233
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2006
    Posted
    July 13, 2006
    Terminated
    December 13, 2006
    Address
    1500 N. Fourth St, Flagstaff, AZ, 86001

    Description

    GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm

    Reason

    Two lots of uniquely different product were switched and mislabeled with the wrong length. 34mm x 10cm devices were mislabeled as 34mm x 15cm and vice versa.

    Action

    All the letters were sent via Federal Express to each Gore Field Sales Associate (FSA) to be hand-delivered to the Physician and to the hospital Risk Manager. A cover note to the FSA directing them regarding the hand delivery of the letter. Also included is a memo to the FSA with a document that the FSA is directed to complete, sign/date and return to Gore documenting hand-delivery of each of these letters. These letters were to be hand delivered on 18 May, or 19 May, 2006.

    Distribution

    Nationwide to: AL, CT, KS, MA, & MN

    Quantity

    10