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U.S. Department of Health and Human Services

Class 2 Device Recall Rita Thermopads

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  Class 2 Device Recall Rita Thermopads see related information
Date Initiated by Firm June 16, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 25, 2004
Recall Number Z-1076-04
Recall Event ID 29383
Product Classification Electrode, Electrosurgical - Product Code JOS
Product Dispersive Electrodes packaged in an 8x10 plastic container.
Code Information Lot codes affected: Y110503-1 and Y103003-2. 510k number : k031926 Contract manufacturer, Katecho, Inc, registration number 1932007
Recalling Firm/
Manufacturer		 Rita Medical Systems
967 N Shoreline Blvd
Mountain View CA 94043-1932
For Additional Information Contact Karen Pickthorn
650-314-3400
Manufacturer Reason
for Recall		 Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.
FDA Determined
Cause 2		 Other
Action Each hospital that has been shipped the devices will receive a recall letter during the week of june 21, 2004 with materials for return shipping. Field representatives will receive notice of the recall, and will return any unused devices and document consumed devices.
Quantity in Commerce 468 sets (each set consists of two pads)
Distribution Product was shipped to 18 field representatives and 87 customers (hospitals and medical centers
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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