BEUDAMED
    FDA Enforcement Class I Ongoing

    Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

    Recall: Z-2095-2025 · Reported July 23, 2025

    Enforcement

    Recall Number
    Z-2095-2025
    Event ID
    97072
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 23, 2025
    Initiation Date
    June 20, 2025
    Classification Date
    July 17, 2025
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

    Reason

    Certain Spectrum infusion pumps may have an incorrect version of software.

    Code Info

    UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523

    Distribution

    US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

    Quantity

    14 units