Home / Recalls / Baxter Healthcare Corp. / Z-0189-2014

Z-0189-2014 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-0189-2014 was initiated by Baxter Healthcare Corp. on Sep 24, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Nov 9, 2016). Affected quantity: 346 units.

Recall Details

Product Type: Devices
Report Date: Nov 20, 2013
Initiation Date: Sep 24, 2013
Termination Date: Nov 9, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 346 units

Product 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 for Recall

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.

Distribution Pattern

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.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0189-2014
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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