CLASS II Device recall · Reported 5 Dec 2018 · FDA Enforcement Report
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate recalled
NxStage Medical is recalling NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis, distributed nationwide in the US. The recall was initiated on 17 Oct 2018 and the FDA has classified it as Class II.
Check your package
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-0500-2019
- FDA event ID
- 81445
- Recalling firm
- NxStage Medical, Lawrence, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2018
- FDA classified
- 27 Nov 2018
- Reported
- 5 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Oct 2018 | Recall initiated by company | |
| 27 Nov 2018 | Classified by FDA | +41 days |
| 5 Dec 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. 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.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot Numbers: F1709268, F1709269, F1709276, F1709277, F1710321, F1711329, F1711334, F1711339, F1711340, F1711341, F1711342, Q1711804, Q1711805, Q1711806, Q1711807, Q1711846, Q1711847, Q1711848, Q1711849, Q1711850, Q1711851, Q1711856, Q1711857, Q1711862, Q1712958, Q1712964, Q1803629, Q1803630, Q1803688, Q1803689, Q1803757, Q1803830, Q1803831, Q1803832
Where was it sold?
US Nationwide Distribution.
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
7 other products · FDA event 81445This product is part of a recall event; the main page for the event is NxStage PureFlow B Solution-RFP-402, Premixed Dialysate recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | NxStage PureFlow B Solution-RFP-402, Premixed Dialysate recalled | NxStage Medical | Other | Nationwide | |
| CLASS II | NxStage PureFlow B Solution-Rfp-rfp recalled by NxStage Medical | NxStage Medical | Other | Nationwide | |
| CLASS II | NxStage PureFlow B Solution-RFP-401, Premixed Dialysate recalled | NxStage Medical | Other | Nationwide | |
| CLASS II | NxStage PureFlow B Solution-Rfp-rfp recalled by NxStage Medical | NxStage Medical | Other | Nationwide | |
| CLASS II | NxStage PureFlow B Solution-RFP-404, Premixed Dialysate recalled | NxStage Medical | Other | Nationwide | |
| CLASS II | NxStage PureFlow B Solution-RFP-406, Premixed Dialysate recalled | NxStage Medical | Other | Nationwide | |
| CLASS II | NxStage PureFlow B Solution-RFP-403, Premixed Dialysate recalled | NxStage Medical | Other | Nationwide |
More recalls from NxStage Medical
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NxStage PureFlow-B Solution recalled by NxStage Medical | NxStage Medical | Packaging Defects | Nationwide |
| Device | CLASS II | NxStage PureFlow-B Solution, Premixed Dialysate recalled | NxStage Medical | Other | Nationwide |
| Device | CLASS II | Low Volume Cartridge IFU recalled by NxStage Medical | NxStage Medical | Other | 5 states |
| Device | CLASS II | NxStage PureFlow B Solution recalled by NxStage Medical | NxStage Medical | Labeling Errors | Nationwide |
| Device | CLASS II | NxStage PureFlow B Solution recalled by NxStage Medical | NxStage Medical | Labeling Errors | Nationwide |
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