Recall Z-0470-03 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Encision, Inc.
AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B
| Date | Jan 30, 2003 (initiated Jan 15, 2003) |
| Status | Terminated |
| Reason | Reports of needle fixed-tip electrodes becoming loose or breaking off. |
| Root cause | Other |
| Action | All consignees will be notified by phone or visit beginning 01/15/2003. |
| Quantity | 58 devices. |
| Distribution | Domestic distribution to LA, MA, MN, OR, UT and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912780 | MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD Electroscope, Inc., Dec 30, 1991 |