Z-1073-2014Class II

NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two...

Name: Z-1073-2014 NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two...
Creator: NxStage Medical, Inc.
Published: 2014-01-24
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2014-01-24 / Terminated / root cause: packaging

FDA source

NxStage Medical, Inc. began a recall of 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... on 2014-01-24. FDA classified it as Class II and gives the reason as "Mislabeled product". 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-1073-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-24
Posted: 2014-02-24
Terminated: 2014-08-29
Recalling firm: NxStage Medical Inc
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.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Mislabeled product.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: NxStage sent a Voluntary Medical Device Recall letter dated January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were asked to check all boxes in inventory for the recalled lot and segregate and quarantine them. In addition, they were asked to complete the recall reply form and return it by fax to NxStage Medical as well as to contact NxStage Customer service to arrange for return of all affected product and for replacement to be sent. Distributor was asked to notify all downstream customers and to provide NxStage Medical with a list of customers. Please complete and fax this form to 978-687-4810 even if you do not have any of the affected product on hand. If you have any questions or comments, please feel free to contact NxStage Customer Service at 1-866- NXSTAGE (1-866-697-8243).
Quantity in commerce: 969 cases (2 bags per case)
Distribution: US Distribution including the states of NY, TX, ID, AR, CA and AL
Product codes and lots: Lot Number: F113662

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1073-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1073-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)