Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with Recalled by NxStage Medical, Inc. Due to Using different fluid formulations of NxStage PureFlow B...
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 with NxStage System One
Quantity: 1243400 units
Why Was This Recalled?
Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About NxStage Medical, Inc.
NxStage Medical, Inc. has 29 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report