Device product
ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices
Z-3032-2017
Product summary
- Firm
- Cenorin, LLC
- Event
- Event 77637
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34 units
- Official record key
device-enforcement:Z-3032-2017
Official wording
Reason: Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
Code information: (a) Serial Numbers: 350423, 350424, 351506, 351507, 351512, 351513, 351514, 351516, 351602, 351604, 351605, 351606, 351609, 351611, 351613, 351614, 351615, 351616, 351617, 351618, 351619, 351620, 351621, 351622, 351623, 351624 (b) Serial numbers: 361505, 361511, 361515, 361601, 361603, 361607, 361608, 361612
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.