NxStage PureFlow-B Solution — Class II medical device recall Z-1864-2025
Ongoing recall by NxStage Medical Inc, reported 2025-06-04, distributed nationwide. Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte f
| Recall number | Z-1864-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage Medical Inc, Lawrence, MA, United States |
| Recall initiated | 2025-04-28 |
| Classified | 2025-05-28 |
| Reported by FDA | 2025-06-04 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| Lot numbers | Q2407061, Q2407062, Q2407063, Q2407064, Q2407065, Q2407066, Q2407067, Q2407068, Q2407069, Q2407070, Q2407071, Q2407072, Q2407137, Q2407138, Q2407139, Q2407140, Q2407141, Q2407142, Q2407143, Q2407144, Q2407145, Q2407146, Q2407147, Q2407148, Q2407149, Q2407213, Q2407214, Q2407216, Q2407217, Q2407218, Q2407219, Q2407220, Q2407221, Q2407222, Q2407223, Q2407224, Q2407225, Q2407226, Q2407227, Q2407301 and 21 more |
| Model numbers | RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456 |
Product
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Reason for recall
Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.
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-1864-2025. 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.