BEUDAMED
    FDA Recall Terminated

    Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.

    Recall: Z-1372-2008 · Initiated December 20, 2007

    Recall

    Recall Number
    Z-1372-2008
    Event Number
    46212
    Firm
    OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    December 20, 2007
    Posted
    July 23, 2008
    Terminated
    July 22, 2008
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.

    Reason

    No Premarket Notification: Product does not have FDA 510(k) approval for use.

    Action

    Consignees were notified by an Urgent Recall Notice letter on 12/20/2007. The letter instructed users to stop using and to dispose of the recalled drapes. For additional information, contact 1-800-874-7378.

    Distribution

    Nationwide Distribution including states of AL, CA, FL, MA, MD, MO, NJ, NY, PA, OR, SC and TX.

    Quantity

    158 units