Device product
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Z-0678-2013
Product summary
- Event
- Event 63768
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,240 units
- Official record key
device-enforcement:Z-0678-2013
Official wording
Reason: GranuFlo Dry Acid Concentrate may show discoloration
Code information: Lot Numbers:12NXGF002, 12NXGF014, 12PXGF006,
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
GranuFlo Dry Acid Concentrate may show discoloration