Baxter SIGMA Spectrum Infusion Pump Software Error Recall
Baxter recalls SIGMA Spectrum Infusion Pump (Version 6) due to potential software error during programming. Affected units may require correction to prevent administration issues.
Lower-risk recall
There is a potential software error during programming.
Contact the company
What happened, in plain English
Baxter is recalling its SIGMA Spectrum Infusion Pump with Master Drug Library (Version . This recall is due to a potential software error during programming that could affect fluid administration. If you own this pump, contact Baxter for details on the fix. Read more at govinfonow.com/recall/63809-baxter-sigma-spectrum-infusion-pump-software-error-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/63809-baxter-sigma-spectrum-infusion-pump-software-error-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0712-2021
Cite this page
“Baxter SIGMA Spectrum Infusion Pump Software Error Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63809-baxter-sigma-spectrum-infusion-pump-software-error-recall. Based on FDA recall #Z-0712-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0712-2021%22&limit=1).
Why it’s dangerous
The software error during programming could lead to incorrect fluid administration. This might cause issues with medication delivery but does not indicate immediate danger to users.
Who’s affected
Healthcare professionals and patients using the Baxter SIGMA Spectrum Infusion Pump (Version 6) with Master Drug Library are affected. Those administering fluids via this pump are most at risk.
How to tell if you have this one
Check for the product code 35700ABB or GTIN 00085412091570 on the pump. This model was intended for controlled fluid administration in healthcare settings.
- Brand
Baxter- Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)- Category
Medical device
All 4 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 II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0712-2021 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.; Product Code 35700ABB, GTIN 00085412091570 | 9,353 devices |
| Z-0713-2021 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.; Product Code 35700BAX, GTIN 00085412091587 | 293,926 devices |
| Z-0714-2021 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.; Product Code 35700BAX2, GTIN 00085412498683 | 140,006 devices |
| Z-0715-2021 | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.; Product Code 3570009, GTIN 00085412610900 | 112,463 devices |
What to do — step by step
Contact Baxter
Reach out to Baxter Healthcare Corporation for specific instructions on correcting the software error.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, 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 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0712-2021 (November 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0712-2021 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.