BEUDAMED
    FDA Enforcement Class II Ongoing

    TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

    Recall: Z-2439-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2439-2025
    Event ID
    97233
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    VANTIVE US HEALTHCARE LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 3, 2025
    Initiation Date
    July 28, 2025
    Classification Date
    August 26, 2025
    Address
    510 Lake Cook Rd, Deerfield, IL, 60015-4964, United States

    Description

    TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

    Reason

    Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted

    Code Info

    UDI 07332414124731, All serial numbers

    Distribution

    Worldwide

    Quantity

    7432 units