BEUDAMED
    FDA Recall Terminated

    Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

    Recall: Z-0051-2013 · Initiated September 24, 2012

    Recall

    Recall Number
    Z-0051-2013
    Event Number
    62059
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    KFM
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 24, 2012
    Posted
    October 11, 2012
    Terminated
    November 13, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

    Reason

    Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.

    Action

    TERUMO sent an Urgent Medical Device Recall dated April 13, 2012, to all affected consignees. An Addendum was sent on September 25, 2012. All US Consignees will receive a Safety Advisory and an update to the Operator's Manual via Federal Express to inform them of the reported malfunction and potential hazards and to raise awareness of the benefits of using a retrograde valve and the importance of back-up system availability. TERUMO will include a customer response form and follow up with all affected users to obtain a response to the recall. For questions customers should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa.

    Quantity

    847 units