Z-1214-2013Class II

NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B...

Name: Z-1214-2013 NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B...
Creator: NxStage Medical, Inc.
Published: 2013-03-18
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2013-03-18 / Terminated / root cause: labeling and UDI

FDA source

NxStage Medical, Inc. began a recall of NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement... on 2013-03-18. FDA classified it as Class II and gives the reason as "Product may be mislabeled". 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-1214-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-18
Posted: 2013-05-02
Terminated: 2014-09-17
Recalling firm: NxStage Medical Inc
Product: NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case 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: Product may be mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: NxStage sent a letter dated March 18, 2013, via email to all consignees instructing them to check their entire inventory and to segregate and quarantine lot F023444 pending further instruction from NxStage. On 4/2/13 NxStage sent a letter via email to all consignees requesting a return of all RFP-400 and RFP-401 labeled with lot F023444.. Consignees were instructed to complete the recall reply form and provide a list of customers (name address, phone number) and fax them to NXStage Medical, Inc. Customers with questions were instructed to call 1-866-697-8243. For questions regarding this recall call 1-866-697-8243.
Quantity in commerce: 1480 cases (2 bags per case)
Distribution: Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
Product codes and lots: F023444

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1214-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1214-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-05-02

Product code KPO

K042045Class IINxstage Pureflow-B SolutionNxstage Medical, Inc. / cleared 2004-08-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)