Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NxStage PureFlow-B Solution Recalled by NxStage Medical Inc Due to The smaller chamber of the two chamber bag...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact NxStage Medical Inc directly.
Affected Products
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
Quantity: 1316936 units
Why Was This Recalled?
The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About NxStage Medical Inc
NxStage Medical Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report