BEUDAMED
    FDA Recall Terminated

    Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.

    Recall: Z-0303-2012 · Initiated October 21, 2011

    Recall

    Recall Number
    Z-0303-2012
    Event Number
    59479
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DWB
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 21, 2011
    Posted
    November 29, 2011
    Terminated
    February 17, 2012
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.

    Reason

    Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection between the board and the transformer.

    Action

    Terumo conducted a Correction/Removal - Customer Communicated Script on November 7, 2011 to the affected customer. The phone script communicated the correction and reason for removal, potential hazards, affected population, and confirmation of possession of affected module. A replacement date was set for November 7, 2011. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818, hours are Monday to Friday. 8 AM -6 PM EST.

    Distribution

    Nationwide Distribution (USA) including the state of San Antonio, TX

    Quantity

    10 units