FDA Device recall Z-1132-2018
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One by Nxstage Medical, citing using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1132-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-10 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nxstage Medical |
| Distribution | US |
Product
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Reason
Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.
Identifiers
| code_info | RFP-400 - M535RFP4000 RFP-400-BB - 00842289101258 RFP-401 M - 535RPF4010 RFP-401-BB - 00842289101265 RFP-402 - M5…RFP-400 - M535RFP4000 RFP-400-BB - 00842289101258 RFP-401 M - 535RPF4010 RFP-401-BB - 00842289101265 RFP-402 - M535RFP4020 RFP-403 - M535RFP4030 RFP-404- M535RFP4040 RFP-405 - M535RFP4050 RFP-406 - M535RFP4060 RFP-453 - M535RFP4530 RFP-454 - M535RFP4540 RFP-455 - M535RFP4550 RFP-456 - M535RFP4560 |
|---|
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-1132-2018%22
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