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Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for h
Recalled November 25, 2015 · FDA recall Z-0294-2016 · Fresenius Medical Care Renal Therapies Group
Hazard
Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire. · FDA Class II
Units
918 units
Sold at
Nationwide Distribution.
Description
Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Product
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
Manufacturer(s)
Fresenius Medical Care Renal Therapies Group, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →