BEUDAMED
    FDA Enforcement Class II Terminated

    SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

    Recall: Z-0197-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0197-2014
    Event ID
    66120
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    June 10, 2013
    Classification Date
    November 8, 2013
    Termination Date
    April 20, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

    Reason

    Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.

    Code Info

    Product Code: 35700BAX, 35700ABB Serial Numbers: All

    Distribution

    Worldwide Distribution-USA including Puerto Rico and Canada.

    Quantity

    273,835 units