ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices
FDA Recall Z-3032-2017 · Posted None
Recalling FirmCenorin, LLC
Recall StatusTerminated
Product CodeJRJ
Date Initiated2017-06-07
Date Terminated2018-05-02
Product Quantity34 units
Reason for Recall
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
Firm Action
Cenorin initially contacted all domestic customers at the facility and distributor level via phone on June 7, 2017, which was followed by an Urgent Medical Device Recall letter dated July 20, 2017, to all affected customers. Cenorin sent initial notification to international distributors via email. Customers were asked to immediately examine their inventory for the affected product. If the product exhibits any symptoms of failure, immediately cease using it and contact Cenorin immediately at [email protected] or call Technical Support at 800-426-1042, ext 224.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.