FDAOctober 23, 2015device

Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

fresenius medical care renal therapiesfreseniusfresenius medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis. — Recall Details · AllClear