BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter Electrocardiograph, ELI 380 -DCS21

    Recall: Z-1013-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1013-2023
    Event ID
    91388
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 1, 2023
    Initiation Date
    October 31, 2022
    Classification Date
    January 24, 2023
    Termination Date
    March 6, 2025
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter Electrocardiograph, ELI 380 -DCS21

    Reason

    One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.

    Code Info

    Lot number 122420001706

    Distribution

    TX

    Quantity

    1 unit