| Class 2 Device Recall ThermaSure | |
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 |
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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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