BEUDAMED
    FDA Enforcement Class II Terminated

    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

    Recall: Z-0314-2018 · Reported January 10, 2018

    Enforcement

    Recall Number
    Z-0314-2018
    Event ID
    77761
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 10, 2018
    Initiation Date
    August 22, 2017
    Classification Date
    January 4, 2018
    Termination Date
    April 14, 2025
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

    Reason

    Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.

    Code Info

    Model No. 3500; Reference No. 3500-0600-51

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.

    Quantity

    9,787 units in total