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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 ThermaSuresee related information
Date Initiated by FirmDecember 21, 2006
Date PostedApril 04, 2007
Recall Status1 Terminated 3 on November 09, 2007
Recall NumberZ-0713-2007
Recall Event ID 37018
Product Classification Drying Cabinet - Product Code LDS
ProductThermaSure 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
FEI Number 3004153171
Recalling Firm/
Manufacturer		 Cenorin
6324 S 199th Pl Ste 107
Kent WA 98032
For Additional Information ContactBeth Robinweiler
253-395-2400
Manufacturer Reason
for Recall		Potential for user to receive an electrical shock.
FDA Determined
Cause 2		Other
ActionLetter 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 Commerce8 units
DistributionWorldwide.
Total Product Life CycleTPLC 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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