FDA-Device2017-08-23Class II

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

Cenorin, LLC
Hazard

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

Sold states
Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel
Affected count
43 units
Manufactured in
6324 S 199th Pl, Suite 107, Kent, WA, United States
Products
ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3033-2017

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