BEUDAMED
    FDA Recall Terminated

    Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit.

    Recall: Z-3214-2011 · Initiated August 29, 2011

    Recall

    Recall Number
    Z-3214-2011
    Event Number
    59528
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DWB
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    August 29, 2011
    Posted
    September 15, 2011
    Terminated
    March 8, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit.

    Reason

    The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.

    Action

    Terumo Cardiovascular Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 29, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter advises customers to make sure all users are aware of the notice. Customers are instructed to complete and return an attached Customer Response Form. Terumo will replace the software on all monitors of the affected product. Customers with questions or concerns should call Terumo CVS Customer Service 1-800-521-2818.

    Distribution

    Worldwide Distribution--USA (nationwide) including the states of AL, AR, CA, CO, GA, IL, IN, MS, NC, OH, TN, VA, and WI and countries of Belgium, Columbia, Hong Kong, India, Singapore, and Taiwan.

    Quantity

    85