NxStage PureFlow-B Solution Recalled for Splashing Hazard

Agency Publication Date: May 28, 2025

Summary

NxStage Medical Inc. is recalling 115,465 cases (approximately 230,930 units) of NxStage PureFlow-B Solution because the seal on the bag's small chamber may fail. If this seal breaks while a user is trying to mix the two chambers before treatment, the electrolyte fluid can splash into the user's face. While no injuries have been reported, consumers should stop using the affected bags and contact the manufacturer or their medical distributor for instructions on returning the product.

Risk

The defect allows electrolyte fluid to splash into a user's face, which could cause eye irritation or other physical injury during the preparation phase of a medical treatment.

What You Should Do

This recall affects NxStage PureFlow-B Solution bags with catalog numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, and RFP-456.
Check the catalog number and lot number printed on the device label or outer carton to see if your product is affected. See the Affected Products section below for the full list of affected codes.
Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or NxStage Medical Inc. for further instructions.
Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement

Option 2: Dispose of Product

How to: Stop using and throw the product away.

Affected Products

Product: NxStage PureFlow-B Solution (RFP-400)

Model / REF:

RFP-400

Lot Numbers:

Q2407307

Q2407308

Q2407309

UDI:

M535RFP4000

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-401)

Model / REF:

RFP-401

Lot Numbers:

Q2407061

Q2407147

Q2407148

Q2407149

Q2407313

Q2407386

Q2407387

Q2407388

Q2407389

Q2407390

UDI:

M535RFP4010

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-402)

Model / REF:

RFP-402

Lot Numbers:

Q2407213

Q2407214

UDI:

M535RFP4020

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-403)

Model / REF:

RFP-403

Lot Numbers:

Q2407311

UDI:

M535RFP4030

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-404)

Model / REF:

RFP-404

Lot Numbers:

Q2407062

Q2407063

Q2407064

Q2407065

Q2407067

Q2407068

Q2407069

Q2407070

Q2407071

Q2407217

Q2407218

Q2407219

Q2407220

Q2407221

Q2407222

Q2407223

Q2407224

Q2407225

Q2407301

Q2407302

Q2407303

Q2407304

Q2407305

Q2407306

Q2407391

Q2407392

Q2407405

Q2407406

UDI:

M535RFP4040

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-406)

Model / REF:

RFP-406

Lot Numbers:

Q2407072

Q2407137

Q2407140

Q2407141

Q2407216

Q2407310

Q2407312

UDI:

M535RFP4060

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-453)

Model / REF:

RFP-453

Lot Numbers:

Q2407066

UDI:

M535RFP4530

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-454)

Model / REF:

RFP-454

Lot Numbers:

Q2407145

Q2407146

Q2407226

UDI:

M535RFP4540

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-456)

Model / REF:

RFP-456

Lot Numbers:

Q2407138

Q2407139

Q2407142

Q2407143

Q2407144

Q2407227

UDI:

M535RFP4560

Recall #: Z-1864-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96730

Status: Active

Manufacturer: NxStage Medical Inc

Sold By: Authorized Medical Distributors

Manufactured In: United States

Units Affected: 115,465 cases (230,930 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects NxStage PureFlow-B Solution bags with catalog numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, and RFP-456.

Check the catalog number and lot number printed on the device label or outer carton to see if your product is affected. See the Affected Products section below for the full list of affected codes.

Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or NxStage Medical Inc. for further instructions.

Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Affected Products

Product: NxStage PureFlow-B Solution (RFP-400)

Model / REF:

RFP-400

Lot Numbers:

Q2407307

Q2407308

Q2407309

UDI:

M535RFP4000

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-401)

Model / REF:

RFP-401

Lot Numbers:

Q2407061

Q2407147

Q2407148

Q2407149

Q2407313

Q2407386

Q2407387

Q2407388

Q2407389

Q2407390

UDI:

M535RFP4010

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-402)

Model / REF:

RFP-402

Lot Numbers:

Q2407213

Q2407214

UDI:

M535RFP4020

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-403)

Model / REF:

RFP-403

Lot Numbers:

Q2407311

UDI:

M535RFP4030

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-404)

Model / REF:

RFP-404

Lot Numbers:

Q2407062

Q2407063

Q2407064

Q2407065

Q2407067

Q2407068

Q2407069

Q2407070

Q2407071

Q2407217

Q2407218

Q2407219

Q2407220

Q2407221

Q2407222

Q2407223

Q2407224

Q2407225

Q2407301

Q2407302

Q2407303

Q2407304

Q2407305

Q2407306

Q2407391

Q2407392

Q2407405

Q2407406

UDI:

M535RFP4040

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-406)

Model / REF:

RFP-406

Lot Numbers:

Q2407072

Q2407137

Q2407140

Q2407141

Q2407216

Q2407310

Q2407312

UDI:

M535RFP4060

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-453)

Model / REF:

RFP-453

Lot Numbers:

Q2407066

UDI:

M535RFP4530

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-454)

Model / REF:

RFP-454

Lot Numbers:

Q2407145

Q2407146

Q2407226

UDI:

M535RFP4540

Recall #: Z-1864-2025

Product: NxStage PureFlow-B Solution (RFP-456)

Model / REF:

RFP-456

Lot Numbers:

Q2407138

Q2407139

Q2407142

Q2407143

Q2407144

Q2407227

UDI:

M535RFP4560

Recall #: Z-1864-2025