BEUDAMED
    FDA Enforcement Class II Ongoing

    PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724

    Recall: Z-2438-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2438-2025
    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 V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724

    Reason

    Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure

    Code Info

    UDI 07332414126018, All serial numbers

    Distribution

    Worldwide

    Quantity

    2449 units