Baxter SIGMA Spectrum Infusion Pump Software Error Recall

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Contact the company & request your remedy

Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy, N/A · 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 its SIGMA Spectrum Infusion Pump with Master Drug Library (Version . This recall is due to a potential software error during programming that could affect device operation.

Why it’s dangerous

The recall is for a potential software error during programming that could affect device operation. This error might lead to incorrect fluid administration if not properly addressed.

Who’s affected

Healthcare professionals using the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) are affected. Patients receiving infusion therapy through this device may be at risk.

How to tell if you have this one

Check for the product code 35700BAX or GTIN 00085412091587 on the device. The pump is intended for controlled fluid administration in healthcare settings.

Brand
Baxter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for the product code 35700BAX or GTIN 00085412091587 on the device label.

✎ GovInfoNow

Questions people ask

Is this pump safe to use?

The recall states there is a potential software error during programming, but no specific safety concerns are described in the record.

What should I do if I have this pump?

The recall record does not specify any remedy or action steps for affected units.

How can I tell if my pump is affected?

Check for the product code 35700BAX or GTIN 00085412091587 on the device label.

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-0713-2021 — Baxter Baxter

Hello,

I own a Baxter that is covered by recall Z-0713-2021 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-0713-2021 (November 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0713-2021 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.

Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the

Recall notice