BEUDAMED
    FDA Recall Terminated

    Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.

    Recall: Z-1458-05 · Initiated July 28, 2005

    Recall

    Recall Number
    Z-1458-05
    Event Number
    32943
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    JTZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2005
    Posted
    August 31, 2005
    Terminated
    October 17, 2005
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.

    Reason

    Microbiological media for antibiotic susceptibility testing gives false test results.

    Action

    The recalling firm notified distributors and direct accounts by fax, e-mail, and letters on 07/28/2005. The notifications advised of false resistant results with control organisms known to be oxcacillin susceptible. Customers were instructed to discontinue use of the lot and discard for replacement. Distributors were requested to discontinue distribution and provide consignee list for subsequent notification. Response forms are included with the recall letters.

    Distribution

    Product was sold to distributors and direct account end-users worldwide including government facilities.

    Quantity

    20930 plates