Z-3034-2017 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
18 units

Product Description

ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 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: 191601, 191602, 191604, 191605, 19161, 191611, 191612, 191613, 191614, 191615, 191616 (b) Serial numbers: 101505, 101506, 101603, 101606, 101607, 101608, 101609