BEUDAMED
    FDA Enforcement Class I Ongoing

    Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS

    Recall: Z-2173-2025 · Reported August 20, 2025

    Enforcement

    Recall Number
    Z-2173-2025
    Event ID
    97164
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2025
    Initiation Date
    July 14, 2025
    Classification Date
    August 14, 2025
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS

    Reason

    Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.

    Code Info

    UDI/DI 05413765851797, All Serial Numbers

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    36705 units