CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report

Baxter Spectrum IQ Infusion System with Dose IQ Safety recalled

Baxter Healthcare is recalling Baxter Spectrum IQ Infusion System with Dose IQ Safety, distributed in Georgia, Idaho. The recall was initiated on 2 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200
Quantity recalled8 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-0348-2025
FDA event ID
95505
Recalling firm
Baxter Healthcare, Deerfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
2 Oct 2024
FDA classified
8 Nov 2024
Reported
20 Nov 2024
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Device Malfunction
Device type
Medical Software

Timeline

2 Oct 2024Recall initiated by company
8 Nov 2024Classified by FDA+37 days
20 Nov 2024Published 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

The door on the Spectrum IQ Infusion pump may not be able to fully close.

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 System with Dose IQ Safety Software, Product Code 3570009

Where it was distributed

GA, ID

GeorgiaIdaho

Questions about this recall

Why was it recalled?

The door on the Spectrum IQ Infusion pump may not be able to fully close.

Which lots are affected?

00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200

Where was it sold?

GA, ID

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

More recalls from Baxter Healthcare

All 577
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIPRO+ 36" MRS Surface, mattress recalled by Baxter HealthcareBaxter HealthcarePackaging DefectsNationwide
DeviceCLASS IIPro+ Mrs Surface For Versacare, mattress recalled by Baxter HealthcareBaxter HealthcarePackaging DefectsNationwide
DeviceCLASS IIVolara System Volara, HC, NA recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
DeviceCLASS IIPRO+ 40" MRS Surface, mattress recalled by Baxter HealthcareBaxter HealthcarePackaging DefectsNationwide
DrugCLASS IDextrose Injection, USP, 70 % recalled by Baxter HealthcareBaxter HealthcareParticulate MatterNationwide

Other Medical Software recalls

All 932
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIIKit: Urinary Clean Catch 20/cs recalled by Medical Action IndustriesMedical Action Industries Inc. 306Device MalfunctionCA
DeviceCLASS IISpectral CT and Spectral CT 7500 RT recalled by Philips Medical SystemsPhilips Medical SystemsDevice MalfunctionNationwide
DeviceCLASS IISmartPath to dStream for XR and 3.0T recalled by Philips North AmericaPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIUpgrade to MR recalled by Philips North AmericaPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIPositron Emission Tomography and Computed Tomography System recalledShanghai United Imaging HealthcareDevice MalfunctionNationwide