Z-3034-2017 Class II Terminated
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