NxStage PureFlow B Solution Recalled Due to Bag Burst Risk
NxStage Medical is recalling 2,189 units of PureFlow B Solution because the bag's smaller chamber can burst, releasing electrolyte fluid that may injure 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 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 2,189 units of NxStage PureFlow B Solution-RFP-403, a premixed dialysate for hemodialysis. The recall affects Lot Numbers Q1802398 and Q1802428, which were distributed nationwide in the United States.
The recall was initiated because the smaller chamber of the two-chamber bag can burst. If this occurs, electrolyte fluid may be released and cause injury if it comes into contact with the eyes or skin.
Consumers and healthcare facilities should stop using the affected product and contact NxStage Medical for further instructions.
The recalled product
- Product
- NxStage PureFlow B Solution-RFP-403, 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.
- Affected units
- 2,189
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 (2)
- Lot Numbers: Q1802398
- Q1802428
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 →Related recalls
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