Device product
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Z-0516-2019
Product summary
- Event
- Event 81451
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4752
- Official record key
device-enforcement:Z-0516-2019
Official wording
Reason: Discolored powder has confirmed the presence of a foreign substance
Code information: Lot code:18ETGF005
Distribution pattern: Distribution US nationwide and Mexico
Derived failure modes
-
Foreign material or chemical contamination
foreign substance