BEUDAMED
    FDA Recall Terminated

    Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280.

    Recall: Z-0233-2007 · Initiated September 14, 2006

    Recall

    Recall Number
    Z-0233-2007
    Event Number
    36150
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 14, 2006
    Posted
    December 7, 2006
    Terminated
    June 19, 2008
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280.

    Reason

    The hand crank handle may separate and detach from the unit during use.

    Action

    Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.

    Distribution

    Worldwide Distribution, USA and Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.

    Quantity

    3