CLASS II Device recall · Reported 5 Dec 2018 · FDA Enforcement Report
NxStage PureFlow B Solution-RFP-401, Premixed Dialysate recalled
NxStage Medical is recalling NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow, 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-0501-2019
- 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
- Sterility
- 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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
NxStage PureFlow B Solution-RFP-401, 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
Is NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow recalled?
Yes. NxStage Medical recalled NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow on 17 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0501-2019.
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: F1708229, F1709262, F1709263, F1709264, F1709265, F1709266, F1709273, F1709274, F1709275, F1709278, F1709279, F1709280, F1709281, F1709282, F1709283, F1709284, F1709286, F1709287, Q1709423, Q1709428, Q1709429, F1710296, F1710297, F1710298, F1710315, F1710316, F1710317, F1710318, F1710319, F1710320, F1710324, F1710325, F1710326, Q1710613, Q1710614, Q1710615, F1711330, F1711337, F1711338, Q1711674, Q1711675, Q1711677, Q1711683, Q1711721, Q1711727, Q1711728, Q1711729, Q1711795, Q1711796, Q1711797, Q1711798, Q1711799, Q1711800, Q1711801, Q1711802, Q1711803, Q1712024, Q1712026, Q1712027, Q1712032, Q1712089, Q1712090, Q1712138, Q1712139, Q1712140, Q1712141, Q1712142, Q1801145, Q1801346, Q1801347, Q1802391, Q1802392, Q1802429, Q1802430, Q1802431, Q1802432, Q1802433, Q1802434, Q1802435, Q1802436, Q1802503, Q1802504, Q1802505, Q1802506, Q1802513, Q1803631, Q1803632, Q1803633, Q1803634, Q1803635, Q1803681, Q1803751, Q1803752, Q1803753, Q1803756, Q1803758, Q1803759, Q1803760, Q1803773, Q1803828, Q1803829, Q1803833, Q1803846, Q1804092, Q1804093, Q1804094, Q1804905
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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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