CLASS II Device recall · Reported 12 Jun 2019 · FDA Enforcement Report

NxStage PureFlow B Solution recalled by NxStage Medical

NxStage Medical is recalling NxStage PureFlow B Solution, distributed nationwide in the US. The recall was initiated on 11 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020

Quantity recalled3,940 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1707-2019
FDA event ID: 82693
Recalling firm: NxStage Medical, Lawrence, MA
Classification: Class II
Status: Terminated
Recall initiated: 11 Apr 2019
FDA classified: 2 Jun 2019
Reported: 12 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

11 Apr 2019	Recall initiated by company
2 Jun 2019	Classified by FDA	+52 days
12 Jun 2019	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Certain lots were mislabeled with incorrect product number.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA

Nationwide Arizona California District of Columbia Florida Georgia Illinois Indiana Michigan North Carolina New Hampshire Nevada Pennsylvania Texas Virginia

Questions about this recall

Why was it recalled?

Certain lots were mislabeled with incorrect product number.

Which lots are affected?

Lot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020

Where was it sold?

US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 82693

Reported	Class	Recall	Company	Reason	Where
12 Jun 2019	CLASS II	NxStage PureFlow B Solution recalled by NxStage Medical	NxStage Medical	Labeling Errors	Nationwide

More recalls from NxStage Medical

All 31

Reported	Class	Recall	Company	Reason	Where
4 Jun 2025Device	CLASS II	NxStage PureFlow-B Solution recalled by NxStage Medical	NxStage Medical	Packaging Defects	Nationwide
26 Jun 2024Device	CLASS II	NxStage PureFlow-B Solution, Premixed Dialysate recalled	NxStage Medical	Other	Nationwide
25 Dec 2019Device	CLASS II	Low Volume Cartridge IFU recalled by NxStage Medical	NxStage Medical	Other	5 states
12 Jun 2019Device	CLASS II	NxStage PureFlow B Solution recalled by NxStage Medical	NxStage Medical	Labeling Errors	Nationwide
5 Dec 2018Device	CLASS II	NxStage PureFlow B Solution-RFP-403, Premixed Dialysate recalled	NxStage Medical	Other	Nationwide

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