BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).

    Recall: Z-0307-2007 · Initiated November 10, 2006

    Recall

    Recall Number
    Z-0307-2007
    Event Number
    36349
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 10, 2006
    Posted
    December 27, 2006
    Terminated
    June 19, 2008
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).

    Reason

    Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.

    Action

    A letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual. Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B.

    Distribution

    Worldwide, including USA, 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

    208