BEUDAMED
    FDA Enforcement Class II Ongoing

    PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

    Recall: Z-2437-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2437-2025
    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

    PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

    Reason

    Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles

    Code Info

    UDI 00085412639499, All Serial Numbers

    Distribution

    Worldwide

    Quantity

    4772 units