BEUDAMED
    FDA Recall Terminated

    Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.

    Recall: Z-0393-05 · Initiated October 31, 2001

    Recall

    Recall Number
    Z-0393-05
    Event Number
    30640
    FEI Number
    3005747797
    Product Code
    GDO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2001
    Posted
    January 13, 2005
    Terminated
    January 31, 2005
    Address
    1 Weck Dr., Weck, Research Triangle Park, NC, 27709

    Description

    Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.

    Reason

    The flush port on some appliers was occluded with an epoxy resin during manufacturing.

    Action

    Consignees were notified by letter on 10/31/2001.

    Distribution

    AL, AZ, CA,CO, CT, FL,GA, KS, NC, NH, NJ, NY, TN, TX, VA,WA.Australia, Singapore, Venezuela.

    Quantity

    66 units