BEUDAMED
    FDA Recall Terminated

    Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line

    Recall: Z-0603-2014 · Initiated June 4, 2013

    Recall

    Recall Number
    Z-0603-2014
    Event Number
    67064
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    3000204839
    Product Code
    MNJ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 4, 2013
    Posted
    December 27, 2013
    Terminated
    October 1, 2014
    Address
    125 Blue Ball Rd, Elkton, MD, 21921-5315

    Description

    Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line

    Reason

    Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.

    Action

    Terumo Cardiovascular issued Customer notification letters on June 4, 2013. Accounts advised to: Review this notice and decide to continue to use or not use the Cardiovascular Procedure Kits as configured until a replacement kit with a one-way valve indicated for use on the arterial side of the perfusion circuit is available. If you have questions, contact Terumo CVS Customer Service: 800-521-2818.

    Distribution

    Nationwide Canada

    Quantity

    24,227.