FDA recall Z-0516-2019
Fresenius Medical Care Renal Therapies Group, LLC · Class III · device
Product
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Reason for recall
Discolored powder has confirmed the presence of a foreign substance
Distribution
Distribution US nationwide and Mexico
Key facts
- Status
- Terminated
- Initiation date
- 2018-10-09
- Report date
- 2018-12-05
- Termination date
- 2021-08-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2019