BEUDAMED
    FDA Enforcement Class I Ongoing

    Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.

    Recall: Z-0327-2025 · Reported November 20, 2024

    Enforcement

    Recall Number
    Z-0327-2025
    Event ID
    95527
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2024
    Initiation Date
    October 16, 2024
    Classification Date
    November 13, 2024
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.

    Reason

    Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

    Code Info

    UDI/DI 07332414124519, All serials with runtime less than 500 hours

    Distribution

    US Nationwide distribution and worldwide

    Quantity

    1100 units