Recall Z-1074-04 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Encision, Inc.
AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
| Date | Sep 22, 2004 (initiated Jun 11, 2004) |
| Status | Terminated |
| Reason | Electrosurgical tip may break or come off during use. |
| Root cause | Other |
| Action | Customers were notified beginning 6/15/2004 by phone or visit. |
| Quantity | 335 units |
| Distribution | AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912780 | MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD Electroscope, Inc., Dec 30, 1991 |