Device product
ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
Z-3034-2017
Product summary
- Firm
- Cenorin, LLC
- Event
- Event 77637
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-3034-2017
Official wording
Reason: Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
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
Distribution pattern: Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel
Derived failure modes
-
Unknown
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.