BEUDAMED
    FDA Enforcement Class I Ongoing

    Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump

    Recall: Z-2334-2025 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2334-2025
    Event ID
    97296
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2025
    Initiation Date
    August 4, 2025
    Classification Date
    August 29, 2025
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump

    Reason

    Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

    Code Info

    UDI/DI N/A, All Serial Numbers

    Distribution

    US distribution including Puerto Rico and OUS (International) Canada

    Quantity

    22703 units