BEUDAMED
    FDA Recall Terminated

    Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery.

    Recall: Z-1924-2011 · Initiated July 29, 2010

    Recall

    Recall Number
    Z-1924-2011
    Event Number
    57141
    Firm
    Quest Medical, Inc
    FEI Number
    3001665800
    Product Code
    DTR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 29, 2010
    Posted
    April 8, 2011
    Terminated
    April 26, 2011
    Address
    1 Allentown Pkwy, Allen, TX, 75002-4206

    Description

    Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery.

    Reason

    User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.

    Action

    Quest Medical Incorporated sent a "User Update" letter in July 2010 to consignees providing information concerning use of external heater-cooler untis with their device - Myocardial Protection System ( MPS) consoles. If you are installing an external heater-water cooler unit or have questions about this user update, please contact the Field Service department at Quest Medical, Inc. The number is 800.627.0026 or 1 972.390.9800.

    Distribution

    Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy

    Quantity

    771 consoles