BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.

    Recall: Z-0206-2009 · Initiated July 18, 2008

    Recall

    Recall Number
    Z-0206-2009
    Event Number
    44852
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 18, 2008
    Posted
    October 31, 2008
    Terminated
    July 7, 2009
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103

    Description

    Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.

    Reason

    Local pump controls including start/stop button, select button and manual button may not function.

    Action

    Consignees were notified by recall letter dated 7/18/08 and were provided with revised operating instructions telling them to revert to the central control module should these problems occur.

    Distribution

    Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.

    Quantity

    300