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U.S. Department of Health and Human Services

Class 2 Device Recall RITA StarBurstXL

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  Class 2 Device Recall RITA StarBurstXL see related information
Date Initiated by Firm April 03, 2007
Date Posted April 19, 2007
Recall Status1 Terminated 3 on January 20, 2010
Recall Number Z-0752-2007
Recall Event ID 37742
510(K)Number K992693  
Product Classification Electro-surgical Device - Product Code GEI
Product RITA¿ Starburst¿ XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
Code Information Part number: 700-101317, Lot number: 22330, 22793, 23297, 23306, 24413, 24655, 25120, 25355, 25425, 25545, 25546, 25547, 25632, 25747, 25748, 25806, 25807, 25808, 25850, 25851, 25876, 25940, 25941, 25971, 25979, 25980, 25981, 26145, 26146, 26456, 26457, 26458, 26496, 26555, 26556, 26581, 26663, 26664, 26930, 26931, 26986, 26987, 27068, 27158, 27168, 27326, 27401, 27437, 27554, 27555, 27711, 27818, 27874, 28189, 28200, 28314, 28462, 28471, 28474, 28556, 28557, 28578, 28635, 28636, 28637, 28709, 28902, 28903, 28965, 28967, 28979, 29041, 29052, 29153, 29250, 29277, 29278, 29426, 29542, 29543, 29670, 29775, 29793 and 29794 Part number 700-101317J (Japanese distribution), Lot numbers 26714, 26715, 27327, 27328, 27329, 27526, 27626, 27969, 28084, 28190, and 28250.
Recalling Firm/
Manufacturer		 Rita Medical Systems, Inc.
1 Horizon Way
Manchester GA 31816-1749
For Additional Information Contact Bruce Maloy
706-846-3216
Manufacturer Reason
for Recall		 The product may have a cracked tray which can compromise the sterility of the product.
FDA Determined
Cause 2		 Other
Action Notification by letter of the AngioDynamics, Inc. sales force and the domestic and international distributors began on April 2, 2007. They were asked to return all affected devices to the Manchester, GA division of AngioDynamics, Inc. A reply form was attached to be completed and returned via fax to AngioDynamics.
Quantity in Commerce 2331 devices
Distribution Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Republic of Ireland, Romania, Russia, Saudi Arabia, Singapore, Solomon Islands, South Africa, Spain, Switzerland, UK, and United Arab Emirates.
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = RITA MEDICAL SYSTEMS
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