BEUDAMED
    FDA Enforcement Class I Terminated

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

    Recall: Z-0120-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0120-2021
    Event ID
    86062
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 28, 2020
    Initiation Date
    June 30, 2020
    Classification Date
    October 22, 2020
    Termination Date
    April 29, 2024
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

    Reason

    Baxter is updating the device IFU for safety communication regarding cleaning practices.

    Code Info

    Product Code: 35700ABB, All Serial Numbers; GTIN 00085412091570

    Distribution

    Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)

    Quantity

    9352 units