Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047 recalled over fire hazard

Recall date

October 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 hem…

Recall number

Z-0294-2016

FDA classification

Class II

Brand / firm

Fresenius Medical Care Renal Therapies Group, LLC

Sold / distributed

Nationwide Distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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