Z-0507-2019Class II

NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is...

Name: Z-0507-2019 NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is...
Creator: NxStage Medical, Inc.
Published: 2018-10-17
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2018-10-17 / Terminated / root cause: packaging

FDA source

NxStage Medical, Inc. began a recall of NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy... on 2018-10-17. FDA classified it as Class II and gives the reason as "PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0507-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-17
Posted: 2018-11-27
Terminated: 2020-08-26
Recalling firm: NxStage Medical Inc
Product: NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Root cause tag: packaging
FDA root cause: Packaging process control
Action: NxStage initiated a recall on October 17, 2018 via " URGENT MEDICAL DEVICE REMOVAL" Recall Notice to its customers. The notice provided reason for recall, health risk, action to be taken. The customers were instructed to do the following: 1 Check all boxes in your Pureflow B solution inventory, separate them from your other inventory and do not use them. 2. Follow the instructions on the attached reply form or click on the following link to respond electronically, https://www.nxstage.com/rfprecalloct2018, to acknowledge your receipt of this notice. 3. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent, If you have any questions or comments, please feel free to contact NxStage Customer Service 1-866- NXST AGE (1-866-697-8243).
Quantity in commerce: 15880
Distribution: US Nationwide Distribution.
Product codes and lots: Lot Numbers: F1708258, F1710322, Q1711910, Q1711911, Q1712093, Q1801227, Q1801342, Q1801343, Q1802393, Q1803816

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0507-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0500-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-27
Z-0501-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-27
Z-0502-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-27
Z-0503-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-27
Z-0504-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-27
Z-0505-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-27
Z-0506-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-27
Z-0507-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-27

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)