NxStage PureFlow B Solution-RFP-401 — Class II medical device recall Z-0501-2019
Terminated recall by NxStage Medical, Inc., reported 2018-12-05, distributed nationwide. PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it
| Recall number | Z-0501-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage Medical, Inc., Lawrence, MA, United States |
| Recall initiated | 2018-10-17 |
| Classified | 2018-11-27 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2020-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 186,476 |
| Lot numbers | F1708229, F1709262, F1709263, F1709264, F1709265, F1709266, F1709273, F1709274, F1709275, F1709278, F1709279, F1709280, F1709281, F1709282, F1709283, F1709284, F1709286, F1709287, F1710296, F1710297, F1710298, F1710315, F1710316, F1710317, F1710318, F1710319, F1710320, F1710324, F1710325, F1710326, F1711330, F1711337, F1711338, Q1709423, Q1709428, Q1709429, Q1710613, Q1710614, Q1710615, Q1711674 and 67 more |
Product
NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Reason for recall
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
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-0501-2019. 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.