Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ThermaSure

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-0712-2007
Recall Event ID 37018
Product Classification Drying Cabinet - Product Code LDS
Product ThermaSure Medical Device Drying Cabinet, series 300
Code Information Catalog #s 090033-02, 090033-04, 090034-02, 090034-04.  Serial Numbers: 330304, 330305, 330306, 330307, 330308, 330309, 330310, 330311, 330312, 330313, 330401, 330402, 330403, 340404, 330405, 340406, 330407, 330408, 330409, 330410, 330411, 340412, 330413, 330414, 330415, 330416, 340417, 340501, 330502, 330503, 330504, 330505, 340506, 330507, 330508, 330509, 330510, 330511, 330512, 330601, 330602, 330603, 330604, 330605, 330606, 330607, 330608, 330609, 330610, 330611.
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 50 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.
-
-