NxStage PureFlow B Solution Recall: Small Chamber Burst Risk

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Contact the company & request your remedy

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 its PureFlow B Solution-RFP- 403 dialysate for hemodialysis. The smaller chamber in the bag could burst, causing injury if electrolyte fluid contacts eyes or skin.

Why it’s dangerous

The smaller chamber in the dialysate bag can burst, releasing electrolyte fluid. If this fluid contacts eyes or skin, it could cause injury. This risk occurs during normal hemodialysis use.

Who’s affected

Hemodialysis patients using NxStage PureFlow B Solution-RFP-403 for kidney treatment. Those with the specific lot numbers Q1802398 or Q1802428 are most at risk.

How to tell if you have this one

Check the lot number on the bag: Q1802398 or Q1802428. The product is used for hemodialysis treatment with renal replacement therapy systems.

Brand
NxStage
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for lot numbers Q1802398 or Q1802428 on the PureFlow B Solution-RFP-403 bag.

✎ GovInfoNow

Questions people ask

What is the specific hazard with this product?

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

What lot numbers are affected?

Lot numbers Q1802398 and Q1802428.

Is there a remedy for this recall?

The recall record does not specify a remedy.

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-0503-2019 — NxStage NxStage

Hello,

I own a NxStage that is covered by recall Z-0503-2019 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-0503-2019 (October 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0503-2019 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-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for

Use caution until it’s fixed