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 Ve…

Recall date

August 27, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0697-2020

FDA classification

Class II

Brand / firm

NxStage Medical, Inc.

Sold / distributed

AL, AZ, CA, NC & VA

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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;