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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-0711-2007
Recall Event ID 37018
Product Classification Drying Cabinet - Product Code LDS
Product ThermaSure Medical Device Drying Cabinet, series 130
Code Information Catalog #s 090035-00, 090035-03, 090036-00, 090036-02.  Serial Numbers: 350305, 350306, 350307, 350308, 360309, 350310, 350311, 360312, 350313, 350314, 350401, 350402, 350403, 350404, 350405, 350406, 350407, 350408, 350409, 350410, 350411, 350412, 350413, 350414, 350415, 350416, 350417, 350418, 350419, 350420, 350421, 350422, 350423, 350424, 350425, 350426, 350427, 350501, 360502, 350503, 350504, 350505, 350506, 350507, 350508, 350509, 350510, 350511, 350512, 350513, 350514, 350515, 350516, 350517, 350518, 360519, 350520, 350521, 350522, 350523, 350524, 350525, 350526, 350527, 350528, 350529, 350530, 360531, 350532, 350533, 350534, 350601, 350602, 350603, 350604, 350605, 350606, 350607, 350608, 350609, 350610, 360611, 360612, 350613, 350614, 350615, 350616, 350617, 350618, 350619, 350620, 350621, 350621A, 350622, 350623, 350624, 350625, 350626, 350627, 350628, 350629.
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 101 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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