FDA-Device2018-12-05Class III
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Fresenius Medical Care Renal Therapies Group, LLC
Hazard
Discolored powder has confirmed the presence of a foreign substance
Sold states
Distribution US nationwide and Mexico
Affected count
4752
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2019Don't want to check this manually?
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