BEUDAMED
    FDA Recall Terminated

    Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck Closure Systems, Research Triangle Park, NC 27709, Sterile, Single use, Disposable.

    Recall: Z-0547-04 · Initiated January 23, 2004

    Recall

    Recall Number
    Z-0547-04
    Event Number
    28248
    FEI Number
    3005747797
    Product Code
    FZP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 23, 2004
    Posted
    February 25, 2004
    Terminated
    May 11, 2004
    Address
    1 Weck Dr., Weck, Research Triangle Park, NC, 27709

    Description

    Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck Closure Systems, Research Triangle Park, NC 27709, Sterile, Single use, Disposable.

    Reason

    Malformation of the Hem-o-lok SMX clip.

    Action

    Consignees were notified by letter via Federal Express (Domestic consignees), Email (International and Weck Sales Representatives), and Fax (Weck Sales Representatives) beginning 01/23/2004.

    Distribution

    Distributors and hospitals in AL, CA, FL, MA, MD, MI, NC, NY, OH, OR, PA, SC, TX, Korea and France

    Quantity

    70 sales units