NxStage PureFlow-B Solution — Class II medical device recall Z-1214-2013
Terminated recall by NxStage Medical, Inc., reported 2013-05-08, distributed nationwide. Product may be mislabeled.
| Recall number | Z-1214-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage Medical, Inc., Lawrence, MA, United States |
| Recall initiated | 2013-03-18 |
| Classified | 2013-05-02 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2014-09-17 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Model numbers | RFP-401 |
Product
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Reason for recall
Product may be mislabeled.
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-1214-2013. 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.