FDAClass IIAugust 23, 2017

ThermaSure(TM) recall

ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices

Why was ThermaSure(TM) recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

(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

Product
ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices
Recalling firm
Cenorin, LLC
Quantity
34 units
Distribution
Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel
Recall date
August 23, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls