BEUDAMED
    FDA Enforcement Class II Terminated

    Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required).

    Recall: Z-0362-2019 · Reported November 7, 2018

    Enforcement

    Recall Number
    Z-0362-2019
    Event ID
    81208
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Vial Sa
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 7, 2018
    Initiation Date
    December 2, 2017
    Classification Date
    November 1, 2018
    Termination Date
    February 11, 2021
    Address
    Le Grand Chemin, N/A, Brezins, N/A, N/A, France

    Description

    Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required).

    Reason

    Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing common software malfunctions.

    Code Info

    Model Catalog Z021135

    Distribution

    Worldwide distribution - US Nationwide and countries of Canada and China.

    Quantity

    7082 units