Z-0714-2021Class II

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) -

Name: Z-0714-2021 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) -
Creator: Baxter Healthcare Corporation
Published: 2020-11-23
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2020-11-23 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids on 2020-11-23. FDA classified it as Class II and gives the reason as "There is a potential software error during programming". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0714-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-23
Posted: 2020-12-23
Recalling firm: Baxter Healthcare Corporation
Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
Product code: FRN Pump, Infusion
Reason for recall: There is a potential software error during programming.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: A Medical Device Correction communication will be sent to all affected customers via U.S.P.S., first class mail. All pumps will be updated with new software which will prevent the malfunction from occurring. The software upgrade will be implemented upon next service or a local Baxter service representative will contact the facility to determine the correction plan and schedule the software update.
Quantity in commerce: 140,006 devices
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Product codes and lots: Product Code 35700BAX2, GTIN 00085412498683

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0714-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0712-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0713-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0714-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0715-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23

Product code FRN

K133801Class IIBaxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation / cleared 2014-05-07

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)