NxStage PureFlow B Solution — Class II medical device recall Z-1707-2019
Terminated recall by NxStage Medical, Inc., reported 2019-06-12, distributed nationwide. Certain lots were mislabeled with incorrect product number.
| Recall number | Z-1707-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage Medical, Inc., Lawrence, MA, United States |
| Recall initiated | 2019-04-11 |
| Classified | 2019-06-02 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2020-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 3,940 units |
| Reason classes | labeling |
| Lot numbers | Q1811789, Q1811790 |
| Model numbers | M535RPF4010, RFP-401 |
| Expiration dates | 2020-11-01 |
Product
NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Reason for recall
Certain lots were mislabeled with incorrect product number.
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-1707-2019. 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.