CLASS I Device recall · Reported 30 Apr 2014 · FDA Enforcement Report

Sigma Spectrum Volumetric Infusion Pump with Master Drug Library recalled

Baxter Healthcare is recalling Sigma Spectrum Volumetric Infusion Pump with Master Drug Library, distributed nationwide in the US. The recall was initiated on 7 Feb 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct Codes: 35700BAX, 35700ABB

Quantity recalled277,096 units (revised)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1484-2014
FDA event ID: 67523
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class I
Status: Terminated
Recall initiated: 7 Feb 2014
FDA classified: 24 Apr 2014
Reported: 30 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Infusion Pumps

Timeline

7 Feb 2014	Recall initiated by company
24 Apr 2014	Classified by FDA	+76 days
30 Apr 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Product Codes: 35700BAX, 35700ABB

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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