BEUDAMED
    FDA Recall Terminated

    Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, DC 20006, Manufactured by: Medimop Medical Projects Ltd, for OMRIX biopharmaceuticals, Utd, MDA blood bank, Sheba Hospital, Romat-Gan, PO8 888, Kiryat Ono 55000 Israel

    Recall: Z-1497-04 · Initiated August 6, 2004

    Recall

    Recall Number
    Z-1497-04
    Event Number
    29728
    Firm
    Omrix Biopharmaceuticals, Ltd. Plasma Fract. Inst. Magen David Adom Blood Services Ctr., Sheba Hospital Ramat Gan Israel
    FEI Number
    3003183625
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 6, 2004
    Posted
    September 30, 2004
    Terminated
    October 29, 2004

    Description

    Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, DC 20006, Manufactured by: Medimop Medical Projects Ltd, for OMRIX biopharmaceuticals, Utd, MDA blood bank, Sheba Hospital, Romat-Gan, PO8 888, Kiryat Ono 55000 Israel

    Reason

    5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port .

    Action

    American Red Cross was notified of the recall on July 25, 2004. Recall letter to the ARC direct accounts was sent out on 8/9/2004.

    Distribution

    The product was shipped from Israel to the American Red Cross distribution center in Louisville, KY. From there, the ARC would ship the product to other distributors and/or directly to 46 hospitals nationwide. There are no govt accounts.