Z-0189-2014Class II

SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B)

Name: Z-0189-2014 SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B)
Creator: Baxter Healthcare Corp.
Published: 2013-09-24
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-09-24 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of 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... on 2013-09-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0189-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-24
Posted: 2013-11-08
Terminated: 2016-11-09
Recalling firm: Baxter Healthcare Corporation
Product: 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.
Product code: FRN Pump, Infusion
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.
FDA root cause: Under Investigation by firm
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.
Quantity in commerce: 346 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0189-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0189-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08

Product code FRN

K042121Class IISpectrum and Spectrum with Master Drug LibrarySigma Intl. / cleared 2004-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)