Low Volume Cartridge IFU — Class II medical device recall Z-0697-2020
Terminated recall by NxStage Medical, Inc., reported 2019-12-25, distributed in AL, AZ, CA, NC, VA. There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting
| Recall number | Z-0697-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage Medical, Inc., Lawrence, MA, United States |
| Recall initiated | 2019-08-27 |
| Classified | 2019-12-18 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2021-02-01 |
| Distributed | AL, AZ, CA, NC, VA |
| Quantity | 1,803 units |
| Lot numbers | 60677021, 60877053, 70477033, 71177020, 80377002, 80477018, 80877011, 81077018, 81177047, 90277048, 90677002 |
| Model numbers | NX1000-1, NX1000-10, NX1000-10-A, NX1000-16, NX1000-16-A, NX1000-3, NX1000-3-A |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0697-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.