FDA recall Z-0697-2020

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;

Reason for recall

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.

Distribution

AL, AZ, CA, NC & VA

Key facts

Status

Terminated

Initiation date

2019-08-27

Report date

2019-12-25

Termination date

2021-02-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lawrence, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0697-2020