FDA Device recall Z-1073-2014
NxStage PureFlow-B Solution
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of NxStage PureFlow-B Solution by Nxstage Medical, citing mislabeled product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1073-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-24 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nxstage Medical |
| Distribution | AL, AR, CA, ID, NY, TX |
Product
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Reason
Mislabeled product.
Identifiers
| code_info | Lot Number: F113662 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 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-1073-2014%22
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