BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0924-2007 · Initiated April 1, 2004

    Recall

    Recall Number
    Z-0924-2007
    Event Number
    37244
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 1, 2004
    Posted
    June 30, 2007
    Terminated
    June 11, 2008
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

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

    Reason

    A belt slip message may be displayed on the roller pump due to low belt tension or the presence of grease.

    Action

    The firm is visiting consignees and making corrections as complaints are received. These corrections, to date, have been made between 04/04 and 09/06. The firm will correct other units as complaints are received and issued a Device Correction Letter dated 6/6 /07 notifying all users of the problem and appropriate responses should it occur.

    Distribution

    Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.

    Quantity

    525 total for both models