Device product
NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Z-1707-2019
Product summary
- Event
- Event 82693
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,940 units
- Official record key
device-enforcement:Z-1707-2019
Official wording
Reason: Certain lots were mislabeled with incorrect product number.
Code information: Lot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020
Distribution pattern: US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA
Derived failure modes
-
Labeling or packaging
mislabeled