ThermaSure recalled over fire hazard

Recall date

June 7, 2017

Source

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

Official notice title

Cenorin, LLC recalls ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer f…

Recall number

Z-3033-2017

FDA classification

Class II

Brand / firm

Cenorin, LLC

Sold / distributed

Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel

Why it was recalled

Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.

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

What was recalled

ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices