NxStage PureFlow B Solution RFP-406 Recall: Small Chamber Burst Risk

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Recalling firmNxStage Medical, Inc.350 Merrimack St, N/A · 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-RFP- 406 dialysate for hemodialysis. The smaller chamber in the bag can burst, potentially causing injury if electrolyte fluid contacts skin or eyes.

Why it’s dangerous

The smaller chamber in the dialysate bag can burst, releasing electrolyte fluid. If this fluid contacts skin or eyes, it could cause injury.

Who’s affected

People using NxStage PureFlow B Solution-RFP-406 for hemodialysis are affected. Those with the specific lot numbers listed are most at risk.

How to tell if you have this one

Check the lot numbers on the bag: F1710314, Q1712034, Q171344, Q1801223, Q1801224, Q1802451, Q1803684, Q1803817, Q1804904.

Brand
NxStage
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for lot numbers on the bag: F1710314, Q1712034, Q171344, Q1801223, Q1801224, Q1802451, Q1803684, Q1803817, Q1804904.

✎ GovInfoNow

Questions people ask

What is the hazard with this product?

The smaller chamber in the dialysate bag can burst, releasing electrolyte fluid that could cause injury if it contacts skin or eyes.

What lot numbers are affected?

Lot numbers F1710314, Q1712034, Q171344, Q1801223, Q1801224, Q1802451, Q1803684, Q1803817, Q1804904.

Do I need to stop using this product?

The recall does not specify a stop-use action; check the lot number to see if it's affected.

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-0505-2019 — NxStage NxStage

Hello,

I own a NxStage that is covered by recall Z-0505-2019 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-0505-2019 (October 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0505-2019 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-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for

Use caution until it’s fixed