Z-1484-2014Class I

SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library

Name: Z-1484-2014 SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library
Creator: Baxter Healthcare Corp.
Published: 2014-02-07
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-02-07 / Terminated / root cause: software

FDA source

Baxter Healthcare Corp. began a recall of SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended... on 2014-02-07. FDA classified it as Class I and gives the reason as "Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1484-2014
Classification: Class I
Status: Terminated
Initiated: 2014-02-07
Posted: 2014-04-25
Terminated: 2017-05-25
Recalling firm: Baxter Healthcare Corporation
Product: SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for 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 has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.
Root cause tag: software
FDA root cause: Software design
Action: On February 7, 2014, Baxter Healthcare Corporation distributed Urgent Device Correction notices and Customer Reply Forms to their customers via first-class mail. Affected customers are instructed to contact Baxter Healthcare Corporation at 1-800-356-3454 (choose option 1) Monday through Friday during the hours of 7:00 am to 7:00 pm Eastern Time. Baxter technicians would determine if an adjustment or repair is necessary. Customers are asked to complete the attached Customer Reply Form and return it to Baxter either by faxing to 1-224-270-5457 or e-mailing a scanned copy to [email protected].
Quantity in commerce: 277,096 units (revised)
Distribution: Worldwide Distribution - USA Nationwide including PR and the country of Canada.
Product codes and lots: Product Codes: 35700BAX, 35700ABB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1484-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1484-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

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)