BEUDAMED
    FDA Enforcement Class I Ongoing

    Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

    Recall: Z-2096-2025 · Reported July 23, 2025

    Enforcement

    Recall Number
    Z-2096-2025
    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 V8, Model Number 35700BAX2

    Reason

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

    Code Info

    UDI-DI: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201

    Distribution

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

    Quantity

    28 units