BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.

    Recall: Z-0292-2007 · Initiated October 6, 2005

    Recall

    Recall Number
    Z-0292-2007
    Event Number
    36392
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 6, 2005
    Posted
    January 9, 2007
    Terminated
    February 1, 2007
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.

    Reason

    Six inch roller pumps were mislabeled as 4 inch roller pumps.

    Action

    The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.

    Distribution

    Worldwide-Michigan and Singapore.

    Quantity

    2