Device product
NxStage PureFlow B Solution-RFP-RFP-456, 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-0507-2019
Product summary
- Event
- Event 81445
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15880
- Official record key
device-enforcement:Z-0507-2019
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: F1708258, F1710322, Q1711910, Q1711911, Q1712093, Q1801227, Q1801342, Q1801343, Q1802393, Q1803816
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