BEUDAMED
    FDA Recall Terminated

    CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA. Private labeled for P.J. Dahlhausen in Germany. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.

    Recall: Z-0471-2009 · Initiated September 20, 2008

    Recall

    Recall Number
    Z-0471-2009
    Event Number
    49495
    Firm
    CAS Medical Systems, Inc.
    FEI Number
    2244861
    Product Code
    KZD
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    September 20, 2008
    Posted
    December 29, 2008
    Terminated
    August 5, 2010
    Address
    44 E Industrial Rd, Branford, CT, 06405

    Description

    CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA. Private labeled for P.J. Dahlhausen in Germany. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.

    Reason

    Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.

    Action

    CAS Medical Systems notified accounts by letter dated 9/19/08 requesting return and sub-recall be conducted to their accounts. The letter was entitled "UNIFUSOR(R) INFUSION CUFFS AND PRIVATE LABEL (CASMED-MANUFACTURED) INFUSION CUFFS *** URGENT PRODUCT CORRECTION NOTICE." For further information, please contact the firm at 203-488-6056.

    Distribution

    Nationwide Foreign: Malaysia, Austria, Belgium, Czech Rep., France, Germany, Greece, Italy, Norway, Spain, Sweden, Switzerland and the UK.

    Quantity

    5,060 pc