CLASS I Device recall · Reported 28 Oct 2020 · FDA Enforcement Report

Baxter Sigma Spectrum Infusion Pump with Master Drug Library recalled

Baxter Healthcare is recalling Baxter Sigma Spectrum Infusion Pump with Master Drug Library (, distributed nationwide in the US. The recall was initiated on 30 Jun 2020 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct Code: 35700ABB, All Serial Numbers; GTIN 00085412091570

Quantity recalled9352 units

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-0120-2021
FDA event ID: 86062
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class I
Status: Terminated
Recall initiated: 30 Jun 2020
FDA classified: 22 Oct 2020
Reported: 28 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Infusion Pumps

Timeline

30 Jun 2020	Recall initiated by company
22 Oct 2020	Classified by FDA	+114 days
28 Oct 2020	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 is updating the device IFU for safety communication regarding cleaning practices.

Product as listed by the FDA

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

Where it was distributed

Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)

Nationwide Puerto Rico

Questions about this recall

Is Baxter Sigma Spectrum Infusion Pump with Master Drug Library ( recalled?

Yes. Baxter Healthcare recalled Baxter Sigma Spectrum Infusion Pump with Master Drug Library ( on 30 Jun 2020. The recall is Class I and its status is Terminated. Recall number Z-0120-2021.

Why was it recalled?

Baxter is updating the device IFU for safety communication regarding cleaning practices.

Which lots are affected?

Product Code: 35700ABB, All Serial Numbers; GTIN 00085412091570

Where was it sold?

Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)

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 21 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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