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Terminated

ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices

FDA Recall Z-3034-2017 · Posted None

Recalling FirmCenorin, LLC
Recall StatusTerminated
Product CodeJRJ
Date Initiated2017-06-07
Date Terminated2018-05-02
Product Quantity18 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.

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