BEUDAMED
    FDA Recall Terminated

    Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135

    Recall: Z-0863-03 · Initiated April 15, 2003

    Recall

    Recall Number
    Z-0863-03
    Event Number
    26093
    FEI Number
    2183870
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 15, 2003
    Posted
    May 22, 2003
    Terminated
    July 2, 2004
    Address
    ev3 Inc. 651 Campus Drive, St. Paul, MN, 55112-3495

    Description

    Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135

    Reason

    The label had an expiration date of August 2005, but the correct expiration date was February 2005.

    Action

    A Device Recall letter dated April 15, 2003 requested that the consignees hold the product for retrieval by the firm's representatives.

    Distribution

    Nationwide in United States.

    Quantity

    15 units