FDA recall Z-3032-2017

Cenorin, LLC · Class II · 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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-06-07
Report date
2017-08-23
Termination date
2018-05-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kent, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3032-2017