BEUDAMED
    FDA Recall Terminated

    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

    Recall: Z-0189-2014 · Initiated September 24, 2013

    Recall

    Recall Number
    Z-0189-2014
    Event Number
    66392
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 24, 2013
    Posted
    November 8, 2013
    Terminated
    November 9, 2016
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during 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 is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge.

    Action

    Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 24, 2013 to all affected customers via first class mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate the affected product, remove them from use and acknowledge your receipt of the recall notification by completing the provided Customer Reply Form and fax to 224-270-5467. Customers were asked to contact Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday during the hourse of 7:00 am and 7:00 pm Eastern Time to order replacement device(s). For technical questions contact Baxter Healthcare Medina at 800-356-3454, (choose option1) and for clinical questions contact Medical Information Services at Baxter 800-933-0303.

    Distribution

    Worldwide Distribution - USA Nationwide in the states of: AR, AZ, CA, CO, CT, FL, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, TN, UT, VA, WA and WV and the country Canada.

    Quantity

    346 units