BEUDAMED
    FDA Recall Terminated

    TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205

    Recall: Z-1517-06 · Initiated June 23, 2006

    Recall

    Recall Number
    Z-1517-06
    Event Number
    36193
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    3003523199
    Product Code
    CBZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 23, 2006
    Posted
    September 29, 2006
    Terminated
    March 22, 2012
    Address
    1311 Valencia Ave, Tustin, CA, 92780-6447

    Description

    TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205

    Reason

    Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance.

    Action

    The affected lots were identified as those lots manufactured in the first quarter of the calendar year 2006. The distribution of affected lots was traced. A letter and a customer response form were developed and each of the five US customers were sent the recall letter via Federal Express. The two international affiliates were contacted and instructed to contact their customers in a manner similar to one used by Terumo CVS in the US. Reconciliation will involve confirmation that the response form for each of the customers and affiliates has been completed and returned to Terumo CVS.

    Distribution

    Nationwide in CA, IL, MA, MD, NC, & OK; Internationally in Belgium & Kuwait

    Quantity

    175