Baxter SIGMA Spectrum Infusion Pump Recall: Flow Testing Risk

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Contact the company & request your remedy

Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Baxter is recalling certain SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) because they were released after repair without full testing, including flow testing. This could lead to improper medication delivery if the pump malfunctions.

Why it’s dangerous

The pumps were released after repair without full testing, which includes flow testing. This could cause improper medication delivery if the pump malfunctions during use.

Who’s affected

Healthcare professionals using the pump for medication delivery are most at risk. Patients receiving infusions through this device may also be affected.

How to tell if you have this one

Check for the product code 35700BAX2 on the pump. The pump has a Master Drug Library (Version 8) and serial number starting with 2153638.

Brand
Baxter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Pump Details
Look for the product code 35700BAX2 and serial number starting with 2153638 on the pump.

✎ GovInfoNow

Questions people ask

Why is this pump being recalled?

The pumps were released after repair without full testing, including flow testing.

What should I do if I have this pump?

The recall record does not specify a remedy or action steps.

Is there a risk of serious injury?

The recall record states the pumps may have flow testing issues after repair, but does not specify injury risks.

Take action

Contact Baxter

We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0776-2025 — Baxter Baxter

Hello,

I own a Baxter that is covered by recall Z-0776-2025 from Baxter.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0776-2025 (November 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0776-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2

Use caution until it’s fixed