BEUDAMED
    FDA Recall Terminated

    Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.

    Recall: Z-0659-2007 · Initiated January 12, 2007

    Recall

    Recall Number
    Z-0659-2007
    Event Number
    37366
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2007
    Posted
    March 27, 2007
    Terminated
    June 19, 2008
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.

    Reason

    The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)

    Action

    Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.

    Distribution

    Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.