LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and assorted Flex Trays(Convenience Kits),
FDA device recall Z-1055-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery
- Reason for recall
- This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubular structures.
- Action taken
- The firm contacted their customers via letter on June 7, 2004. The suspect product and Flex Tray kits will be returned and destroyed.
- Root cause
- Other
- Status
- Terminated
- Product code
- GDO
- Quantity affected
- 120,4015
- Distribution
- The product was shipped to hospitals and distributors nationwide and worldwide.
- Date initiated
- 2004-06-07
- Date posted
- 2004-07-20
- Date terminated
- 2008-10-29
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIGACLIP 20/20* MULTIPLE CLIP APPLIER (K864102) | ETHICON, Inc. | 1986-11-05 |