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

Spectrum IQ Infusion System with Dose IQ Safety recalled

Baxter Healthcare is recalling Spectrum IQ Infusion System with Dose IQ Safety, 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: 3570009, All Serial Numbers; GTIN 00085412610900

Quantity recalled146,224 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-0123-2021
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: Device Malfunction
Device type: Medical Software

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Spectrum IQ Infusion System with Dose IQ Safety Software

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

Why was it recalled?

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

Which lots are affected?

Product Code: 3570009, All Serial Numbers; GTIN 00085412610900

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 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.

Other products in this recall event

3 other products · FDA event 86062

This product is part of a recall event; the main page for the event is Baxter Sigma Spectrum Infusion Pump with Master Drug Library recalled.

Reported	Class	Recall	Company	Reason	Where
28 Oct 2020	CLASS I	Baxter Sigma Spectrum Infusion Pump with Master Drug Library recalled	Baxter Healthcare	Other	Nationwide
28 Oct 2020	CLASS I	Baxter Sigma Spectrum Infusion Pump with Master Drug Library recalled	Baxter Healthcare	Other	Nationwide
28 Oct 2020	CLASS I	Baxter Sigma Spectrum Infusion Pump with Master Drug Library recalled	Baxter Healthcare	Other	Nationwide

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