BEUDAMED
    FDA Enforcement Class II Ongoing

    Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

    Recall: Z-1964-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1964-2025
    Event ID
    96822
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2025
    Initiation Date
    May 12, 2025
    Classification Date
    June 12, 2025
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

    Reason

    Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.

    Code Info

    UDI/DI 05413765852428, All Serial Numbers

    Distribution

    US Nationwide distribution.

    Quantity

    8027 units