BEUDAMED
    FDA Recall Terminated

    Ref No. 523470 Hemoclip, 15 Large Stainless Steel Clips/Cartridge and Ref. No. 523670 Hemoclip, 10 Large Stainless Steel Clips/Cartridge

    Recall: Z-1390-04 · Initiated October 24, 2003

    Recall

    Recall Number
    Z-1390-04
    Event Number
    29820
    FEI Number
    3005747797
    Product Code
    HBT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 24, 2003
    Posted
    August 24, 2004
    Terminated
    August 25, 2004
    Address
    1 Weck Dr., Weck, Research Triangle Park, NC, 27709

    Description

    Ref No. 523470 Hemoclip, 15 Large Stainless Steel Clips/Cartridge and Ref. No. 523670 Hemoclip, 10 Large Stainless Steel Clips/Cartridge

    Reason

    Hole in the sterile unit blister pack that could compromise sterility.

    Action

    The consignees were notified of the recall via letter beginning October 24, 2003 asking for return of the product.

    Distribution

    Nationwide and to accounts in Canada, Europe Asia, and South/Latin America

    Quantity

    91,869 units for all products under recall