Recall Z-0752-2007 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Rita Medical Systems, Inc.
RITA Starburst XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
| Date | Apr 19, 2007 (initiated Apr 3, 2007) |
| Status | Terminated |
| Reason | The product may have a cracked tray which can compromise the sterility of the product. |
| Root cause | 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 | 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, Sw |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992693 | RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90 Rita Medical Systems, Sep 10, 1999 |