Recall Z-2635-2010 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
Ethicon Endo-Surgery Inc
Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05
| Date | Sep 30, 2010 (initiated Jul 9, 2010) |
| Status | Terminated |
| Reason | The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection. |
| Root cause | Other |
| Action | Ethicon Endo-Surgery issued an Urgent: Device Recall, Event 2193 letter dated July 19, 2010 identifying the affected device, the issue prompting the recall, and actions to be taken by consignees. Consignees were instructed: Do not use the affected product. Identify and quarantine affected product from inventory. Complete the Business Reply form and fax to Stericycle at 877-597-9580 within three days To return product, place it in a box with a copy of the Business Reply form and mail to Stericycle using the pre-printed UPS shipping label. Replacement product should be received by the customer w |
| Quantity | 396 instruments |
| Distribution | Nationwide Distribution to the following states: AZ, AL, AZ, CA, CO, CT, FL, GA, IN, KY, MA, MD, MI, MO, MS, NC, NV, NY, OH, PA, TN, TX, WA, and WV. |
| FDA record | Open on fda.gov |