Agency classClass IIOur severity:High FDA (Devices)·Z-0504-2019·Announced 2018-12-05

NxStage PureFlow B Solution Recalled for Potential Bag Burst Injury Risk

NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential injury without confirmed cases.

Plain-English summary

NxStage Medical, Inc. is recalling 114,777 units of NxStage PureFlow B Solution-RFP-404, a premixed dialysate for hemodialysis. The product is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

The recall was initiated because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid. This fluid can cause injury if it comes into contact with the eyes or skin. The affected lots were distributed nationwide in the United States.

Consumers and healthcare providers should stop using the affected product immediately. The specific lot numbers subject to this recall are listed in the agency's official documentation. Users should contact the manufacturer or their healthcare provider for further instructions on how to proceed.

The recalled product

Product: NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Manufacturer: NxStage Medical, Inc.
Category: Medical Device — Dialysis Solution
Hazard: chemical-burn
eye-injury
skin-injury
Affected units: 114,777

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)

Lot Numbers: F1708230
F1708231
F1708234
F1708235
F1708237
F1708245
F1708246
F1708247
F1708250
F1708251
F1708253
F1708254
F1708256
F1709260
F1709261
F1709267
F1710327
F1710328
F1711343
F1711344

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by NxStage Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · NxStage Medical, Inc.

See all →

High
NxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk
FDA (Devices) · 2025-06-04
High
NxStage PureFlow-B Hemodialysis Solution Bags Recalled Due to Bursting Chambers and Caustic Fluid
FDA (Devices) · 2024-06-26
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

Same hazard · chemical burn