Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems,
FDA device recall Z-0031-06 · posted 2005-10-07 · Terminated
Recall details
- Recalling firm
- Rita Medical Systems
- Reason for recall
- Devices for which sterility may be compromised as evidenced by a loss of package integrity.
- Action taken
- On 9/21/05, the firm issued letters via UPS to all its direct consignees, informing them of the affected product and providing instructions on the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Distribution
- Product was released for distribution to 63 consignees nationwide. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled produc
- Date initiated
- 2005-09-21
- Date posted
- 2005-10-07
- Date terminated
- 2006-01-03
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HABIB 4X (K051420) | Emcision , Ltd. | 2005-08-15 |