Device product
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Z-1214-2013
Product summary
- Event
- Event 64820
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1480 cases (2 bags per case)
- Official record key
device-enforcement:Z-1214-2013
Official wording
Reason: Product may be mislabeled.
Code information: F023444
Distribution pattern: Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
Derived failure modes
-
Labeling or packaging
mislabeled