FDA Device recall Z-1707-2019
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
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy syste… by Nxstage Medical, citing certain lots were mislabeled with incorrect product number.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1707-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-11 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nxstage Medical |
| Distribution | US |
Product
NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Reason
Certain lots were mislabeled with incorrect product number.
Identifiers
| code_info | Lot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1707-2019%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.