FDA Device recall Z-0503-2019
NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
- FDA Device
- Class II
- terminated
- Published 2018-12-05
On 2018-12-05 the FDA classified a Class II recall of NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac… by Nxstage Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0503-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-17 |
| Published | 2018-12-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nxstage Medical |
| Distribution | US |
Product
NxStage PureFlow B Solution-RFP-403, 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
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
Identifiers
| code_info | Lot Numbers: Q1802398, Q1802428 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Nxstage Medical
- NxStage PureFlow-B Solution
FDA Device · Class II · 2025-06-04 · 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
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0503-2019%22
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