Recall Z-3034-2017— Cenorin, LLC

Name: FDA recall Z-3034-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-07

Class II · Terminated

Class II FDA medical device recall by Cenorin, LLC, initiated 2017-06-07, terminated 2018-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices. Reason: Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn..

Recalling firm: Cenorin, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-06-07
Terminated: 2018-05-02
Firm location: Kent, WA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.