CLASS I ONGOING Device recall · Reported 9 Feb 2022 · FDA Enforcement Report

Baxter Spectrum IQ Infusion Pumps, Product recalled by Baxter Healthcare

Baxter Healthcare is recalling Baxter Spectrum IQ Infusion Pumps, Product, distributed nationwide in the US. The recall was initiated on 29 Dec 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll serial numbers, GTIN 00085412610900.

Quantity recalled241,304 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-0529-2022
FDA event ID: 89017
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class I
Status: Ongoing
Recall initiated: 29 Dec 2021
FDA classified: 28 Jan 2022
Reported: 9 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

29 Dec 2021	Recall initiated by company
28 Jan 2022	Classified by FDA	+30 days
9 Feb 2022	Published in enforcement report	+12 days

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

Reason for recall

There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.

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

Baxter Spectrum IQ Infusion Pumps, Product code 3570009.

Where it was distributed

Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago.

Nationwide Puerto Rico

Questions about this recall

Is Baxter Spectrum IQ Infusion Pumps, Product recalled?

Yes. Baxter Healthcare recalled Baxter Spectrum IQ Infusion Pumps, Product on 29 Dec 2021. The recall is Class I and its status is Ongoing. Recall number Z-0529-2022.

Why was it recalled?

Which lots are affected?

All serial numbers, GTIN 00085412610900.

Where was it sold?

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.

More recalls from Baxter Healthcare

All 564

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
9 Sep 2026Drug	CLASS I	9% Sodium Chloride Injection USP, Viaflex recalled by Baxter HealthcareSodium Chloride	Baxter Healthcare	Particulate Matter	IL
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Drug	CLASS II	Clindamycin Phosphate in 9% Sodium Chloride Injection recalledClindamycin Phosphate	Baxter Healthcare	Sterility	Nationwide

Other Infusion Pumps recalls

All 546

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide