BEUDAMED
    FDA Recall Terminated

    Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate boxes (100 pkgs) per case. The label shows the product is Manufactured by Southwest Technologies, Inc., North Kansas City, MO.

    Recall: Z-0841-06 · Initiated March 27, 2006

    Recall

    Recall Number
    Z-0841-06
    Event Number
    35051
    Firm
    Southwest Technologies Inc
    FEI Number
    1929833
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 27, 2006
    Posted
    May 4, 2006
    Terminated
    December 12, 2007
    Address
    1746 E Levee St N, Kansas City, MO, 64116-4404

    Description

    Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate boxes (100 pkgs) per case. The label shows the product is Manufactured by Southwest Technologies, Inc., North Kansas City, MO.

    Reason

    The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.

    Action

    Recall letters were sent to all direct accounts via certified mail on 3/27/2006. The consignees were requested to return any affected product on hand and if the product was further distributed, notify their customers.

    Distribution

    Product was distributed to direct accounts in the United States and Belgium.

    Quantity

    90 cases of Product DR8000; 56 cases or Product DR8000LV; and 28 cases of Product DR8050. Each case contained 100 units.