Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1707-2019·Announced 2019-06-12

NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling

NxStage Medical is recalling specific lots of PureFlow B Solution because they were mislabeled with the incorrect product number.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the issue as a labeling error (incorrect product number) without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.

Plain-English summary

NxStage Medical, Inc. is recalling 3,940 units of NxStage PureFlow B Solution, Reference RFP-401, Model M535RPF4010. The recall involves Lot Numbers Q1811789 and Q1811790, which have an expiration date of 11/1/2020. This product is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

The reason for the recall is that certain lots were mislabeled with an incorrect product number. The affected units were distributed nationwide in Arizona, California, the District of Columbia, Florida, Georgia, Illinois, Indiana, Michigan, North Carolina, New Hampshire, Nevada, Pennsylvania, Texas, and Virginia.

Consumers and healthcare facilities should check their inventory for these specific lot numbers and product references. If the product is found, it should be removed from use and returned to the supplier or NxStage Medical, Inc. according to their instructions.

The recalled product

Product: NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 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: mis-labeling
Affected units: 3,940

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 (1)

Lot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · NxStage Medical, Inc.

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NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
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Same hazard · mis labeling