Fresenius Modified Mixer Motor 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 Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid conce…

Recall number

Z-0296-2016

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 Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.