Device product
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Z-1073-2014
Product summary
- Event
- Event 67405
- Status
- Terminated
- Classification
- Class II
- Quantity
- 969 cases (2 bags per case)
- Official record key
device-enforcement:Z-1073-2014
Official wording
Reason: Mislabeled product.
Code information: Lot Number: F113662
Distribution pattern: US Distribution including the states of NY, TX, ID, AR, CA and AL
Derived failure modes
-
Labeling or packaging
Mislabeled