BEUDAMED
    FDA Enforcement Class I Ongoing

    Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

    Recall: Z-1253-2025 · Reported March 12, 2025

    Enforcement

    Recall Number
    Z-1253-2025
    Event ID
    96289
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 12, 2025
    Initiation Date
    February 5, 2025
    Classification Date
    March 6, 2025
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

    Reason

    There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

    Code Info

    UDI/DI 00085412091570, Serial Numbers: 704198, 728888, 751492, 758399, 758614, 761662, 763197, 766291, 772611, 773302, 775486, 778837, 785425, 793453, 795240, 798065, 814485, 818850, 826637, 850214, 850854, 851500, 854157, 855803, 863354, 870307, 873114, 876483, 877014, 877102, 889153, 896292, 900181, 906422, 907176, 912242, 913562, 927864, 938265, 958176, 962828, 963975, 965158, 974676, 981605, 982459, 984154, 986132, 986634, 989053, 993087, 994417, 994842, 995538, 997153, 1006359, 1011058, 1013925, 1014064, 1014529, 1014856, 1017150, 1017546, 1018229, 1018703, 1024109

    Distribution

    US: Nationwide

    Quantity

    66 units