Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NxStage PureFlow-B Solution. Catalog numbers: RFP-400 Recalled by NxStage Medical Inc Due to Potential for the perimeter seal on the small...
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. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Quantity: 115,465 cases (230,930 units)
Why Was This Recalled?
Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.
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