BEUDAMED
    FDA Recall Terminated

    Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    Recall: Z-2782-2011 · Initiated June 21, 2011

    Recall

    Recall Number
    Z-2782-2011
    Event Number
    57012
    Firm
    Bard Access Systems
    FEI Number
    3006260740
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 21, 2011
    Posted
    July 11, 2011
    Terminated
    July 11, 2012
    Address
    605 North 5600, West Salt Lake City, UT, 84116-3738

    Description

    Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    Reason

    Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.

    Action

    Bard Access Systems, Inc sent out an "Urgent" Medical Device Recall (User Level)" dated June 2011 to all affected customers The letter included: product name, description of problem and requested the return of units bearing "B50" on the fan. Bard Access Systems, Inc. will replace the incorrect fan with the correct fan. For additional information call 1-724-779-3000.

    Distribution

    Nationwide (USA) distribution including the states of AL, AR, AZ, CA, CO, FL, IA, IN, MD, MI, MO, MS, NC, NJ, NM, NY, OH, PA, RI, SC, TX, UT, VA, VT, and WA.

    Quantity

    86 units