NxStage PureFlow-B Solution recallZ-1132-2018 · NxStage Medical, Inc. · initiated Nov 10, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from NxStage Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling design
What the company is doing
Customers are advised to : 1. Always make sure when using PureFlow B Solution that fluid is flowing freely from all bags. 2. Recognize that any practice of hanging more than one fluid type at the same time is not an intended use of the NxStage System One" (as it does not monitor fluid composition) and is not a labeled indication of PureFlow B solutions. 3. Please make sure that all users of PureFlow B Solution in your organization and other concerned persons are informed regarding this Field Safety Notice. 4. Complete the enclosed customer reply form and return it to NxStage. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices.
Recall details
- Recall number
- Z-1132-2018
- Status
- Terminated
- Initiated by the company
- Nov 10, 2017
- Recalling firm
- NxStage Medical, Inc.
- Quantity
- 1243400 units
- Product code
- KPO
- FDA submissions
- K053286
- Distribution
- US nationwide distribution
Product description
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- NxStage PureFlow-B Solution RFP-400-BBNxstage Medical, Inc. · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)1 recall0 reports
- NxStage PureFlow-B Solution RFP-401-BBNxstage Medical, Inc. · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page