BEUDAMED
    FDA Enforcement Class II Terminated

    Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K

    Recall: Z-1619-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1619-2014
    Event ID
    68042
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 21, 2014
    Initiation Date
    April 25, 2014
    Classification Date
    May 13, 2014
    Termination Date
    May 18, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521, United States

    Description

    Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K

    Reason

    2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump

    Code Info

    Revision K Actuator Test Boards

    Distribution

    USA (nationwide) and the country of Canada.*

    Quantity

    39 units