BEUDAMED
    FDA Enforcement Class II Terminated

    SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.

    Recall: Z-2738-2014 · Reported October 8, 2014

    Enforcement

    Recall Number
    Z-2738-2014
    Event ID
    69122
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 8, 2014
    Initiation Date
    September 3, 2014
    Classification Date
    September 30, 2014
    Termination Date
    March 16, 2017
    Address
    25212 W. Illinois Route 120, N/A, Round Lake, IL, 60073-9799, United States

    Description

    SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.

    Reason

    One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.

    Code Info

    Software Versions 5.02.06, 6.02.06, and 6.02.11; Affected Serial Numbers: 712090, 723687, 723842, 724966, 725820, 735977, 751130, 752124, 755174, 768538, 771990, 774743, 781406, 783736, 784698, 794466, 805797, 808901, 809113, 812462, 815932, 842120, 857926, 858672, 862085, 863721, 865630, 873459, 889597, 890260, 903748, 912619, 920574, 920589, 956346, 957394, 965402, 966684, 976931, 977550, 978361, 983979, 984066, 984129, 984475, 985946, 987538, 993445, 995291, 996014, 996389, 1013037, 1004377, 1014565, 1014962, 967887, 950671, and 938428.

    Distribution

    Worldwide Distribution -- USA and Canada.

    Quantity

    USA: 56 units, Canada: 2 units