RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One H
FDA device recall Z-0753-2007 · posted 2007-04-19 · Terminated
Recall details
- Recalling firm
- Rita Medical Systems, Inc.
- Reason for recall
- The product may have a cracked tray which can compromise the sterility of the product.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 751 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, Rep
- Date initiated
- 2007-04-03
- Date posted
- 2007-04-19
- Date terminated
- 2010-01-20
- Location
- Manchester, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RITA MODEL 70 ELECTROSURGICAL PROBE (K983871) | Rita Medical Systems | 1998-12-01 |