BEUDAMED
    FDA Enforcement Class I Ongoing

    Baxter Exactamix Pro 1200, REF EXM12DY

    Recall: Z-1001-2024 · Reported February 28, 2024

    Enforcement

    Recall Number
    Z-1001-2024
    Event ID
    93700
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2024
    Initiation Date
    December 22, 2023
    Classification Date
    February 16, 2024
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter Exactamix Pro 1200, REF EXM12DY

    Reason

    An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.

    Code Info

    UDI/DI 05413765588150, Serial Numbers: PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, LD2339005

    Distribution

    US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI,

    Quantity

    8 devices