Recall Z-0215-04 ยท HET Laparoscope, Gynecologic (And Accessories)
Ethicon Endo-Surgery
FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD063.
| Date | Dec 17, 2003 (initiated Nov 25, 2003) |
| Status | Terminated |
| Reason | A defective articulation band may result in improper staple formation with possible hematosis. |
| Root cause | Nonconforming Material/Component |
| Action | The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed. |
| Quantity | 210 |
| Distribution | The product was shipped to hospitals and distributors located nationwide and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.