XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set *
FDA device recall Z-0888-06 · posted 2006-05-31 · Terminated
Recall details
- Recalling firm
- Rita Medical Systems, Inc.
- Reason for recall
- Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker
- Action taken
- Consignees were first notified by telephone on 05/02/2006. A follow up letter was sent on 05/03/2006. The European Medical Device Agency, the Italian Competent Authority and British Standards Institution were notified by email on 05/03/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 19 units
- Distribution
- AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy
- Date initiated
- 2006-05-02
- Date posted
- 2006-05-31
- Date terminated
- 2008-02-05
- 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 STARBURST XLI ELECTROSURGICAL DEVICE (K010060) | Rita Medical Systems | 2001-01-23 |