BEUDAMED
    FDA Enforcement Class II Ongoing

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

    Recall: Z-0713-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0713-2021
    Event ID
    86758
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2020
    Initiation Date
    November 23, 2020
    Classification Date
    December 23, 2020
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

    Reason

    There is a potential software error during programming.

    Code Info

    Product Code 35700BAX, GTIN 00085412091587

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.

    Quantity

    293,926 devices