BEUDAMED
    FDA Recall Terminated

    Baxter Electrocardiograph, ELI 380 -DCS21

    Recall: Z-1013-2023 · Initiated October 31, 2022

    Recall

    Recall Number
    Z-1013-2023
    Event Number
    91388
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    DPS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 31, 2022
    Posted
    January 24, 2023
    Terminated
    March 6, 2025
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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.

    Action

    The customer was contacted on 31 October 2022 to inform them of the issue and instructed not to install the device for use.

    Distribution

    TX

    Quantity

    1 unit