BEUDAMED
    FDA Enforcement Class II Terminated

    Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature

    Recall: Z-1569-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1569-2013
    Event ID
    64530
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    May 30, 2013
    Classification Date
    June 21, 2013
    Termination Date
    September 17, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586, United States

    Description

    Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature

    Reason

    Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.

    Code Info

    Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663.

    Distribution

    Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA

    Quantity

    7 units