Agency classClass IIOur severity:High FDA (Devices)·Z-2160-2024·Announced 2024-06-26

NxStage PureFlow-B Hemodialysis Solution Bags Recalled Due to Bursting Chambers and Caustic Fluid

NxStage PureFlow-B hemodialysis solution bags may burst during preparation, releasing caustic electrolyte fluid that can cause chemical burns. Affected units are distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a documented mechanical failure (bursting chambers) and a caustic hazard (pH < 2.0 electrolyte fluid). Although no illnesses or injuries have been reported, the product poses a clear risk of chemical burn and slip/fall injury upon contact with skin, eyes, or spillage.

Plain-English summary

NxStage PureFlow-B Solution is a premixed dialysate (electrolyte solution) for hemodialysis used in kidney dialysis treatment. The FDA recall affects 1,316,936 units with catalog numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, and RFP-456, distributed nationwide.

Healthcare workers have reported that the smaller chamber in the two-chamber bags bursts when attempting to mix the chambers before use. The electrolyte fluid in the smaller chamber has a pH below 2.0, making it caustic and potentially harmful. If the chamber ruptures, the caustic fluid can contact skin or eyes, causing chemical burns. Spilled fluid also poses a slip and fall hazard.

This recall affects dialysis centers, hospitals, and other healthcare facilities nationwide that use this product.

The recalled product

Product: NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
Manufacturer: NxStage Medical Inc
Category: Medical Device — Hemodialysis Dialysate
Hazard: chemical-burn-risk
caustic-fluid
container-failure
slip-fall-risk
Affected units: 1,316,936

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Catalog Number: RFP-400
Primary Device Identifier: M535RFP4000
Catalog Number: RFP-401
Primary Device Identifier: M535RFP4010
Catalog Number: RFP-402
Primary Device Identifier: M535RFP4020
Catalog Number: RFP-403
Primary Device Identifier: M535RFP4030
Catalog Number: RFP-404
Primary Device Identifier: M535RFP4040
Catalog Number: RFP-405
Primary Device Identifier: M535RFP4050
Catalog Number: RFP-406
Primary Device Identifier: M535RFP4060
Catalog Number: RFP-453
Primary Device Identifier: M535RFP4530
Catalog Number: RFP-454
Primary Device Identifier: M535RFP4540
Catalog Number: RFP-456
Primary Device Identifier: M535RFP4560

Distribution

Distributed nationwide across the United States.

Same manufacturer · NxStage Medical Inc

See all →

High
NxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk
FDA (Devices) · 2025-06-04
High
NxStage Low Volume Cartridge Recalled for Hemodialysis Risk
FDA (Devices) · 2019-12-25
Moderate
NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
FDA (Devices) · 2019-06-12
Moderate
NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
FDA (Devices) · 2019-06-12
High
NxStage PureFlow B Solution Recalled Due to Bag Burst Risk
FDA (Devices) · 2018-12-05

Same hazard · chemical burn risk