Device recall: SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion…

Class I FDA enforcement event 67523. Recall start date: 7 Feb 2014. Status in the FDA record: Terminated. Termination date: 25 May 2017.

Reason for recall, in the words of FDA

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.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Baxter Healthcare Corp. started this device recall on 7 Feb 2014. The firm address in the FDA record is in Deerfield, IL. FDA put the recall in Class I. FDA event 67523 has 1 product record. The first FDA enforcement report date is 30 Apr 2014. The record gives the status Terminated, with the termination date 25 May 2017.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - USA Nationwide including PR and the country of Canada.

Recalling firm

Baxter Healthcare Corp., Deerfield, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 67523: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1484-2014	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…	277,096 units (revised)	Class I	Terminated	30 Apr 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2014: 1,176
Share of these events in Class I: 5%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 83

Other events of the firm

Other FDA enforcement events of Baxter Healthcare Corp.
Initiated	Product (first record)	Type	Class	Records
1 Sep 2017	Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479	Device	Class II	1
12 Oct 2016	GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dial	Device	Class II	1
28 Sep 2016	sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 3	Device	Class II	3
24 Jun 2016	Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106	Device	Class II	1
23 May 2016	PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy	Device	Class II	1
12 May 2016	COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemos	Device	Class II	3
21 Apr 2016	GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Devic	Device	Class II	5
12 Apr 2016	Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL,	Drug	Class II	1
16 Feb 2016	Automated peritoneal dialysis (APD) cycler	Device	Class II	1
5 Feb 2016	0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Produc	Drug	Class II	1

Baxter Healthcare Corp.: all 83 events

Official channels

FDA enforcement report Z-1484-2014The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 67523. https://recallregister.com/fda/i/67523/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - USA Nationwide including PR and the country of Canada.
What quantity of product is in FDA event 67523?: The FDA record gives this quantity: 277,096 units (revised)
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2014 have the same class?: 5% of the 1,176 device events that started in 2014 are in Class I.