NxStage PureFlow B Solution — Class II medical device recall Z-1132-2018
Terminated recall by NxStage Medical, Inc., reported 2018-03-28, distributed nationwide. Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause
| Recall number | Z-1132-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage Medical, Inc., Lawrence, MA, United States |
| Recall initiated | 2017-11-10 |
| Classified | 2018-03-19 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2019-12-06 |
| Distributed | Nationwide (US) |
| Quantity | 1,243,400 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00842289101258, 00842289101265 |
Product
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Reason for recall
Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.
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-1132-2018. 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.