Recall Z-1055-04 ยท GDO Applier, Surgical, Clip
Ethicon Endo-Surgery
LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and assorted Flex Trays(Convenience Kits), containing ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers.
| Date | Jul 20, 2004 (initiated Jun 7, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The firm contacted their customers via letter on June 7, 2004. The suspect product and Flex Tray kits will be returned and destroyed. |
| Quantity | 120,4015 |
| Distribution | The product was shipped to hospitals and distributors nationwide and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K864102 | LIGACLIP 20/20* MULTIPLE CLIP APPLIER ETHICON, Inc., Nov 5, 1986 |