Device product
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Z-0677-2013
Product summary
- Event
- Event 63768
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,782 units
- Official record key
device-enforcement:Z-0677-2013
Official wording
Reason: GranuFlo Dry Acid Concentrate may show discoloration
Code information: Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
GranuFlo Dry Acid Concentrate may show discoloration