Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Low Volume Cartridge IFU (SKU CAR-125-B) used with the following Recalled by NxStage Medical, Inc. Due to There is a potential patient health risk while...
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
Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A;
Quantity: 1803 units
Why Was This Recalled?
There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing larger dialysate volumes.
Where Was This Sold?
This product was distributed to 5 states: AL, AZ, CA, NC, VA
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