Z-3033-2017 Class II Terminated

Recalled by Cenorin, LLC — Kent, WA

Recall Details

Product Type
Devices
Report Date
August 23, 2017
Initiation Date
June 7, 2017
Termination Date
May 2, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

(a) Serial Numbers: 331517, 331518, 331523, 331524, 331525, 331526, 331527, 331528, 331529, 331530, 331601, 331608, 331609, 331612, 331615, 331616, 331621, 331622, 331623, 331624, 331625, 331626, 331627 (b) Serial numbers: 341506, 341507, 341516, 341520, 341521, 341522, 341602, 341603, 341604, 341605, 341606, 341607, 341610, 341611, 341613, 341614, 341617, 341618, 341619, 341620