RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
This recall has been terminated (originally issued April 19, 2007).
- Company
- Rita Medical Systems, Inc.
- Recall Initiated
- April 3, 2007
- Posted
- April 19, 2007
- Terminated
- January 20, 2010
- Recall Number
- Z-0753-2007
- Quantity
- 751 devices
- Firm Location
- Manchester, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The product may have a cracked tray which can compromise the sterility of the product.
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.
Lot / Code Info
Product number: 700-101493, Lot number: 22442, 25551, 26583, 26937, 27439, 27807 & 29778 and Product number: 700-101493J (Japanese distribution), Lot number: 25599, 25640, 25641, 25642, 25982, 26718, 26719, 26805, 26806, 27045, 27177, 27716, 27717, 27808, 27809, 27941, 27959, 27960, 27975, 27976, 27977, 28436, 28437, 28438, 28518, 28519, 28520, 28521, 28522, 28523, 28524, 28558, 28582, 28583 & 28584
Root Cause
Other
Action Taken
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.