Device product
NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Z-0503-2019
Product summary
- Event
- Event 81445
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2189
- Official record key
device-enforcement:Z-0503-2019
Official wording
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
Code information: Lot Numbers: Q1802398, Q1802428
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
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