NxStage PureFlow B Solution Recall: Mislabeling Risk

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Contact the company & request your remedy

Recalling firmNxStage Medical, Inc.350 Merrimack St · Lawrence, MA 01843-1748

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

NxStage is recalling specific lots of PureFlow B Solution for hemodialysis use because they were mislabeled with the wrong product number. This could cause incorrect treatment if the wrong solution is used. The recall affects patients using these specific lot numbers for kidney dialysis.

Why it’s dangerous

Mislabeling means the solution might be used incorrectly in hemodialysis treatment. This could lead to improper dialysis if the wrong product is administered. However, the hazard does not involve immediate injury or death.

Who’s affected

Patients using NxStage PureFlow B Solution for hemodialysis are affected. Those with specific lot numbers Q1811789 or Q1811790 are most at risk.

How to tell if you have this one

Check the lot number on the PureFlow B Solution container. Affected lots are Q1811789 and Q1811790, expiring November 1, 2020.

Brand
NxStage
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for the lot number on the PureFlow B Solution container. Affected lots are Q1811789 and Q1811790.

✎ GovInfoNow

Questions people ask

What is the specific product being recalled?

NxStage PureFlow B Solution (lot numbers Q1811789 and Q1811790) for hemodialysis use.

Why is this product being recalled?

The product was mislabeled with the incorrect product number, which could lead to incorrect use in hemodialysis.

How can I check if my product is affected?

Check the lot number on the container. Affected lots are Q1811789 and Q1811790, expiring November 1, 2020.

Take action

Contact NxStage

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

✉️ Open in email

Subject: Recall Z-1707-2019 — NxStage NxStage

Hello,

I own a NxStage that is covered by recall Z-1707-2019 from NxStage.

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-1707-2019 (April 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1707-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

NxStage Medical, Inc. recalls NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal

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