FDA Device recall Z-0504-2019
NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
- FDA Device
- Class II
- terminated
- Published 2018-12-05
On 2018-12-05 the FDA classified a Class II recall of NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac… by Nxstage Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0504-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-17 |
| Published | 2018-12-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nxstage Medical |
| Distribution | US |
Product
NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Reason
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
Identifiers
| code_info | Lot Numbers: F1708230, F1708231, F1708234, F1708235, F1708237, F1708245, F1708246, F1708247, F1708250, F1708251, F170…Lot Numbers: F1708230, F1708231, F1708234, F1708235, F1708237, F1708245, F1708246, F1708247, F1708250, F1708251, F1708253, F1708254, F1708256, F1709260, F1709261, F1709267, F1710327, F1710328, F1711343, F1711344, F1711345, Q1711844, Q1711853, Q1711854, Q1711855, Q1712025, Q1712091, Q1712092, Q1712137, Q1801146, Q1801147, Q1801148, Q1801149, Q1801151, Q1801202, Q1801221, Q1801225, Q1801226, Q1801335, Q1801336, Q1801337, Q1801338, Q1801339, Q1801340, Q1802507, Q1802508, Q1802509, Q1802510, Q1802511, Q1802512, Q1803685, Q1803686, Q1803687, Q1803690, Q1803750, Q1803754, Q1803755, Q1803774, Q1803775, Q1803776, Q1803847, Q1803848, Q1803849, Q1804888 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0504-2019%22
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