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U.S. Department of Health and Human Services

Class 2 Device Recall ThermaSure(TM), a CENORIN(TM) product, 300 Series

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  Class 2 Device Recall ThermaSure(TM), a CENORIN(TM) product, 300 Series see related information
Date Initiated by Firm June 07, 2017
Create Date August 14, 2017
Recall Status1 Terminated 3 on May 02, 2018
Recall Number Z-3033-2017
Recall Event ID 77637
Product Classification Unit, drying - Product Code JRJ
Product ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340

Forced air dryer for medical devices
Code Information (a) Serial Numbers: 331517, 331518, 331523, 331524, 331525, 331526, 331527, 331528, 331529, 331530, 331601, 331608, 331609, 331612, 331615,  331616, 331621, 331622, 331623, 331624, 331625, 331626, 331627   (b) Serial numbers: 341506, 341507, 341516, 341520, 341521, 341522, 341602,  341603, 341604, 341605, 341606, 341607, 341610, 341611, 341613, 341614,  341617, 341618, 341619, 341620  
Recalling Firm/
Manufacturer
Cenorin, LLC
6324 S 199th Pl
Suite 107
Kent WA 98032
For Additional Information Contact
253-395-2400
Manufacturer Reason
for Recall
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
FDA Determined
Cause 2
Process control
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 recall@cenorin.com or call Technical Support at 800-426-1042, ext 224.
Quantity in Commerce 43 units
Distribution Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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