Recall Z-0778-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Megadyne Medical Products, Inc
Rocker Switch Electrosurgical Pencil with E-Z Clean Tip
| Date | Apr 19, 2006 (initiated Apr 6, 2006) |
| Status | Terminated |
| Reason | Surgical device packaging may be damaged and may compromise sterility. |
| Root cause | Other |
| Action | Consignees were notified by letter on 04/06/2006. |
| Quantity | 34,132 units |
| Distribution | Nationwide, including one VA facility in OH. No military consignees. Foreign distribution to France, India, Ireland, Japan, South Korea, Malaysia, Poland, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965054 | PENCIL Megadyne Medical Products, Inc., Jan 24, 1997 |