Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

Recalled December 5, 2018 · FDA recall Z-0516-2019 · Fresenius Medical Care Renal Therapies Group

Hazard

Discolored powder has confirmed the presence of a foreign substance · FDA Class III

Units

4752

Sold at

Distribution US nationwide and Mexico

Description

Discolored powder has confirmed the presence of a foreign substance

Product

Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

Manufacturer(s)

Fresenius Medical Care Renal Therapies Group, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →