Z-0197-2014Class II

SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration...

Name: Z-0197-2014 SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration...
Creator: Baxter Healthcare Corp.
Published: 2013-06-10
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-06-10 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids on 2013-06-10. FDA classified it as Class II and gives the reason as "Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0197-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-10
Posted: 2013-11-08
Terminated: 2017-04-20
Recalling firm: Baxter Healthcare Corporation
Product: SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Product code: FRN Pump, Infusion
Reason for recall: Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On June 10, 2013 Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Library. The notices were dated June 5, 2013 and were distributed via first class mail. Until further information is provided, users should continue to follow the SIGMA SPECTRUM Infusion Pump Operator's Manual, which identifies a number of environmental and clinical usage factors that contribute to upstream occlusion and air-in-line alarms. For high-risk patients, consider having additional devices as backup. If the biomedical engineer finds that the sensor is not functioning properly, contact Baxter Healthcare at 800-356-3454 (choose option 1). For clinical questions, please contact Medical Information Services at Baxter at 800-933-0303, Monday through Friday 8:00am to 5:00 pm Central Time.
Quantity in commerce: 273,835 units
Distribution: Worldwide Distribution-USA including Puerto Rico and Canada.
Product codes and lots: Product Code: 35700BAX, 35700ABB Serial Numbers: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0197-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0197-2014	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)