FDA Device recall Z-1864-2025
NxStage PureFlow-B Solution
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of NxStage PureFlow-B Solution by Nxstage Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1864-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-28 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Nxstage Medical |
| Distribution | US |
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
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.
Identifiers
| code_info | a. UDI-DI number: M535RFP4000. Device Catalog Number RFP-400. Lot Numbers: Q2407307, Q2407308, Q2407309. b. UDI-DI nu…a. UDI-DI number: M535RFP4000. Device Catalog Number RFP-400. Lot Numbers: Q2407307, Q2407308, Q2407309. b. UDI-DI number: M535RFP4010. Device Catalog Number RFP-401. Lot Numbers: Q2407061, Q2407147, Q2407148, Q2407149, Q2407313, Q2407386, Q2407387, Q2407388, Q2407389, Q2407390. c. UDI-DI number: M535RFP4020. Device Catalog Number RFP-402. Lot Numbers: Q2407213, Q2407214. d. UDI-DI number: M535RFP4030. Device Catalog Number RFP-403. Lot Number: Q2407311. e. UDI-DI number: M535RFP4040. Device Catalog Number RFP-404. Lot Numbers: Q2407062, Q2407063, Q2407064, Q2407065, Q2407067, Q2407068, Q2407069, Q2407070, Q2407071, Q2407217, Q2407218, Q2407219, Q2407220, Q2407221, Q2407222, Q2407223, Q2407224, Q2407225, Q2407301, Q2407302, Q2407303, Q2407304, Q2407305, Q2407306, Q2407391, Q2407392, Q2407405, Q2407406. f. UDI-DI number: M535RFP4060. Device Catalog Number RFP-406. Lot Numbers: Q2407072, Q2407137, Q2407140, Q2407141, Q2407216, Q2407310, Q2407312. g. UDI-DI number: M535RFP4530 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Nxstage Medical
- NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-4…
FDA Device · Class II · 2024-06-26 · Nxstage Medical - Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1
FDA Device · Class II · 2019-12-25 · Nxstage Medical - NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement thera…
FDA Device · Class II · 2019-06-12 · Nxstage Medical - NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy syste…
FDA Device · Class II · 2019-06-12 · Nxstage Medical - NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal re…
FDA Device · Class II · 2018-12-05 · Nxstage Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1864-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.