Baxter Prismaflex Control Unit Software Below 7.21 May Cause Therapy Interruption

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Baxter Healthcare is recalling Prismaflex Control Units with software versions older than 7.21. These units may cause therapy interruptions or blood loss if communication errors occur. This is serious for patients using blood filtration systems.

Why it’s dangerous

The software versions below 7.21 can have communication errors that interrupt therapy or cause blood loss. This happens when the system fails to properly manage blood flow in the extracorporeal circuit.

Who’s affected

Patients using Baxter's Prismaflex blood filtration systems with older software versions are most at risk. Healthcare providers managing these systems may also be affected.

How to tell if you have this one

Check for product code 113081 and software versions below 7.21. All lot numbers are affected, and the GTIN is 07332414105266.

Brand
Baxter Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Look for the software version on your Prismaflex Control Unit; versions below 7.21 are affected.
Contact Baxter
Reach out to Baxter Healthcare for guidance on next steps if your unit is affected.

✎ GovInfoNow

Questions people ask

What software versions are affected?

Software versions below 7.21 are affected.

How can I tell if my unit is recalled?

Check for product code 113081 and software versions below 7.21. All lot numbers are affected.

What should I do if my unit is affected?

Contact Baxter Healthcare for guidance on next steps.

Take action

Contact Baxter Healthcare

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

✉️ Open in email

Subject: Recall Z-0277-2020 — Baxter Healthcare Baxter Healthcare

Hello,

I own a Baxter Healthcare that is covered by recall Z-0277-2020 from Baxter Healthcare.

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-0277-2020 (October 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0277-2020 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 Prismaflex Control Unit, software versions below 7.21

Use caution until it’s fixed