FDA Device recall Z-0697-2020
Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1
- FDA Device
- Class II
- terminated
- Published 2019-12-25
On 2019-12-25 the FDA classified a Class II recall of Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1 by Nxstage Medical, citing 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 pati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0697-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-27 |
| Published | 2019-12-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nxstage Medical |
| Distribution | AL, AZ, CA, NC, VA |
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
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.
Identifiers
| code_info | Product 1) UDI # - M535NX100010 Product 2) UDI # - M535NX1000160 and M535NX100016A0 Product 3) UDI # - M535NX100030 a…Product 1) UDI # - M535NX100010 Product 2) UDI # - M535NX1000160 and M535NX100016A0 Product 3) UDI # - M535NX100030 and M535NX10003A0 Product 4) UDI # - M535NX1000100 and M535NX100010A0 Lot Numbers: 60677021, 60877053, 70477033, 71177020, 80377002, 80477018, 80877011, 81077018, 81177047, 90277048 and 90677002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0697-2020%22
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