Use cautionMedical device recall · FDA · Published December 29, 2021
Baxter Spectrum IQ Infusion Pumps Recall: Risk of Medication Not Delivered
Baxter recalls Spectrum IQ Infusion Pumps (product code 3570009) due to potential medication delivery issues from incorrect setup or unresolved alarms. Affected units have specific serial numbers and GTIN.
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.
Take action
Contact the company
📍Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
“Baxter Spectrum IQ Infusion Pumps Recall: Risk of Medication Not Delivered.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61328-baxter-spectrum-iq-infusion-pumps-recall-risk-of-medication-not. Based on FDA recall #Z-0529-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0529-2022%22&limit=1).
Baxter Healthcare Corporation recalled Baxter Spectrum IQ Infusion Pumps, product code 3570009, due to the potential for reduced or non-delivery of medication without an alarm. The Food and Drug Administration announced this Class I recall on December 29, 2021.
How to tell if you have it
Baxter Spectrum IQ Infusion Pumps, Product code 3570009
UPC 00085412610900
The hazard
The recall addresses 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.
Context
GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since September 2, 2015. Other recent recalls include a PRO+ MRS SURFACE FOR VERSACARE mattress recall (August 18, 2026), a 0.9% Sodium Chloride Injection recall for fiberglass particulates (August 17, 2026), and a Dextrose 2000mL Bags recall for stainless steel particles (August 17, 2026). Similar recent recalls of infusion devices include an ICU Medical Plum Duo IV Pump recall (April 29, 2026), a Boston Scientific Intera 3000 Hepatic Artery Pump recall (May 11, 2026), and an ICU Medical Plum Duo Infusion Pump recall (April 29, 2026).
How to tell if you have this one
Check for the product code 3570009 on the pump or its documentation. Affected units have specific serial numbers and GTIN 00085412610900.
Brand
Baxter
Product
Baxter Spectrum IQ Infusion Pumps, Product code 3570009
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
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.
Recall number
Product, codes & lots
Quantity
Z-0529-2022
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.; All serial numbers, GTIN 00085412610900.
241,304 units
Z-0530-2022
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.; All serial numbers, GTIN 00085412498683.
146,502 units
Based on the official FDA remedy
What to do — step by step
Check Pump Settings
Ensure the administration set is correctly set up and upstream occlusion alarms are fully resolved to prevent medication delivery issues.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0529-2022 (December 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0529-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.