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U.S. Department of Health and Human Services

Class 2 Device Recall ThermaSure

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  Class 2 Device Recall ThermaSure see related information
Date Initiated by Firm December 21, 2006
Date Posted April 04, 2007
Recall Status1 Terminated 3 on November 09, 2007
Recall Number Z-0713-2007
Recall Event ID 37018
Product Classification Drying Cabinet - Product Code LDS
Product ThermaSure Medical Device Drying Cabinet, series 1000
Code Information Catalog #s 090010-02, 090010-04, 090011-00, 090011-02.   Serial Numbers: 100401, 100402, 100403, 100404, 100501, 100601, 100602, 100603
Recalling Firm/
Manufacturer		 Cenorin
6324 S 199th Pl Ste 107
Kent WA 98032
For Additional Information Contact Beth Robinweiler
253-395-2400
Manufacturer Reason
for Recall		 Potential for user to receive an electrical shock.
FDA Determined
Cause 2		 Other
Action Letter dated 12/20/2006 notifying customers of potential shock hazard under certain fault conditions and that a corrective action upgrade is being developed.
Quantity in Commerce 8 units
Distribution Worldwide.
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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