BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1 Roller Pump; 6 inch diameter; Catalog number 801040.

    Recall: Z-0103-04 · Initiated October 16, 2003

    Recall

    Recall Number
    Z-0103-04
    Event Number
    27604
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 16, 2003
    Posted
    November 7, 2003
    Terminated
    July 7, 2005
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1 Roller Pump; 6 inch diameter; Catalog number 801040.

    Reason

    The roller pump tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion.

    Action

    Letters entitled Urgent Safety Alerts were sent to each customer on 10/16/03. Customers were made away of the problem and advised to develop a protocol for action, in case the problem occurred in their facility.

    Distribution

    United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Singapore, South Korea.

    Quantity

    263