BEUDAMED
    FDA Recall Terminated

    Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.

    Recall: Z-0617-2007 · Initiated December 12, 2006

    Recall

    Recall Number
    Z-0617-2007
    Event Number
    36962
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    KFM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 12, 2006
    Posted
    March 14, 2007
    Terminated
    June 19, 2008
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.

    Reason

    Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.

    Action

    Consignees will be notified via letter dated 12/12/06, which provides instructions for identifying defective manual drives and to contact the firm if their unit is defective.

    Distribution

    Woldwide, including USA, Canada, and Mexico

    Quantity

    2696