NxStage PureFlow B Solution Recalled Due to Bag Bursting Risk
NxStage Medical is recalling 7,275 units of PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall, and the source text explicitly states that the defect can cause injury to eyes or skin, meeting the criteria for a Severe rating.
Plain-English summary
NxStage Medical, Inc. is recalling 7,275 units of NxStage PureFlow B Solution-RFP-RFP-454, a premixed dialysate for hemodialysis. The recall covers lots Q1801222, Q1801341, Q1802396, and Q1802397, 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.
Healthcare providers and patients should stop using the affected lots immediately and contact NxStage Medical for instructions on returning the product or obtaining replacements.
The recalled product
- Product
- NxStage PureFlow B Solution-RFP-RFP-454, 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
- 7,275
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 (4)
- Lot Numbers: Q1801222
- Q1801341
- Q1802396
- Q1802397
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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