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NxStage Medical, Inc. recalls Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage
Recalled December 25, 2019 · FDA recall Z-0697-2020 · NxStage Medical
Hazard
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. · FDA Class II
Units
1803 units
Sold at
AL, AZ, CA, NC & VA
Description
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.
Product
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;
Manufacturer(s)
NxStage Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →