BEUDAMED
    FDA Enforcement Class II 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 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0189-2014
    Event ID
    66392
    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
    September 24, 2013
    Classification Date
    November 8, 2013
    Termination Date
    November 9, 2016
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    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.

    Code Info

    Product Code: 35700BAX & 35700ABB; Serial Numbers: 433713, 435563, 704056, 707290, 715315, 724216, 740127, 752318, 752447, 753675, 754947, 759766, 765934, 770034, 772017, 773470, 776507, 781016, 781969, 783352, 783454, 787567, 789720, 791225, 794828, 794990, 797185, 804798, 808393, 808764, 810971, 812076, 818718, 821213, 824067, 824198, 839143, 850028, 850577, 852007, 852431, 855450, 860201, 864799, 876765, 877548, 877944, 878637, 879810, 879886, 880022, 884707, 884778, 885565, 889416, 889814, 890949, 890987, 894957, 895413, 896662, 896912, 897576, 900401, 904778, 913511, 915035, 915981, 916173, 916948, 919159, 921162, 921937, 922515, 923861, 945583, 953011, 953360, 953995, 955881, 959847, 967694, 978892, 981692, 986022, 997333, 998512, 1002325, 1018432, 1018436, 1018737

    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