BEUDAMED
    FDA Recall Terminated

    ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. The component that is the subject of the recall is the AT1 Autotransfusion Set.

    Recall: Z-0906-03 · Initiated January 21, 2003

    Recall

    Recall Number
    Z-0906-03
    Event Number
    25528
    Firm
    Fresenius Hemocare, Inc.
    FEI Number
    3002987955
    Product Code
    CAC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 21, 2003
    Posted
    June 5, 2003
    Terminated
    June 4, 2003
    Address
    6675 185th Ave. NE, Suite 100, Redmond, WA, 98052

    Description

    ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. The component that is the subject of the recall is the AT1 Autotransfusion Set.

    Reason

    Sterility may be compromised

    Action

    On 1/21/03 the firm notified, via telephone, the distributor of the product. The distributor was advised to return any unused product and to contact their customers for return of product. This was followed by a letter 1/21/03 sent via e-mail. The distributor in turn contacted their customers on 1/23/03 by telephone. This was followed by a letter dated 1/23/03.

    Distribution

    All ATF 40 kits were distributed to one distributor located in MI. The distributor in turn distributed product to 21 hospitals and medical centers in AL, FL, NE, KS, MI, NE, NJ, NY, OH, PA, TX, VA, and WA.

    Quantity

    ATF40 - 1264 (648 of AT1 suspect batch NHT272 were used, the remainder were of different batches)