BEUDAMED
    FDA Enforcement Class I Terminated

    SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

    Recall: Z-1484-2014 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1484-2014
    Event ID
    67523
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2014
    Initiation Date
    February 7, 2014
    Classification Date
    April 24, 2014
    Termination Date
    May 25, 2017
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

    Reason

    Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.

    Code Info

    Product Codes: 35700BAX, 35700ABB

    Distribution

    Worldwide Distribution - USA Nationwide including PR and the country of Canada.

    Quantity

    277,096 units (revised)