BEUDAMED
    FDA Enforcement Class II Ongoing

    Spectrum IQ Infusion Pump, Product Code 3570009

    Recall: Z-2415-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2415-2025
    Event ID
    97335
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 3, 2025
    Initiation Date
    July 14, 2025
    Classification Date
    August 22, 2025
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Spectrum IQ Infusion Pump, Product Code 3570009

    Reason

    Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.

    Code Info

    UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271

    Distribution

    US distribution to states of: AZ, FL

    Quantity

    6 units