Device product
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Z-0681-2013
Product summary
- Event
- Event 63768
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,689 units
- Official record key
device-enforcement:Z-0681-2013
Official wording
Reason: GranuFlo Dry Acid Concentrate may show discoloration
Code information: Lot Numbers:12NXGF011, 12PXGF004
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
GranuFlo Dry Acid Concentrate may show discoloration