Z-1132-2018Class II

NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One

Name: Z-1132-2018 NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Creator: NxStage Medical, Inc.
Published: 2017-11-10
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2017-11-10 / Terminated / root cause: labeling and UDI

FDA source

NxStage Medical, Inc. began a recall of NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One on 2017-11-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1132-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-10
Posted: 2018-03-19
Terminated: 2019-12-06
Recalling firm: NxStage Medical Inc
Product: NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Quantity in commerce: 1243400 units
Distribution: US nationwide distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1132-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1132-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19

Product code KPO

K053286Class IIModification to: Nxstage Pureflow-B SolutionNxstage Medical, Inc. / cleared 2005-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)