Z-1707-2019Class II

NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with...

Name: Z-1707-2019 NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with...
Creator: NxStage Medical, Inc.
Published: 2019-04-11
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2019-04-11 / Terminated / root cause: labeling and UDI

FDA source

NxStage Medical, Inc. began a recall of NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize... on 2019-04-11. FDA classified it as Class II and gives the reason as "Certain lots were mislabeled with incorrect product number". 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-1707-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-11
Posted: 2019-06-02
Terminated: 2020-06-08
Recalling firm: NxStage Medical Inc
Product: NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 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: Certain lots were mislabeled with incorrect product number.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On April 11, 2019, NxStage Medical Inc. issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service. Customers were advised to take the following actions: 1. Check all boxes in your Pureflow B solution inventory. If you find any boxes or individual bags of Pureflow B solution from the affected lots listed in the table below, separate them from your other inventory and do not use them. Refer to Appendix A for pictures to assist in locating part or SKU and lot number of your Pureflow B solution inventory. 2. Promptly complete and return the online response form at the link www.novasyte.com/nxstageapr2019 to acknowledge your receipt of this notice, even if you do not have the affected product on hand. 3. Upon completion of the online response form, your facility will be scheduled for a product return pick up date based on the availability you provide. NxStage is partnered with Novasyte to assist in this action. Novasyte specializes in providing outsourced commercial service teams and technologies for the medical device industry. For any assistance regarding this action please contact Novasyte using the information below: Phone: (760) 205-3020 Email: [email protected]
Quantity in commerce: 3,940 units
Distribution: US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA
Product codes and lots: Lot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1707-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1706-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-02
Z-1707-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-02

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)