Recall Z-0469-03 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Megadyne Medical Products, Inc
Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE
| Date | Jan 30, 2003 (initiated Dec 20, 2002) |
| Status | Terminated |
| Reason | The metal substrate cautery tip may break during use. |
| Root cause | Other |
| Action | On 12/20/2002, all consignees were notified by letter to return all affected product. |
| Quantity | 4855 |
| Distribution | Nationwide. Foreign distribution to Australia, Belgium, Canada, Italy, Korea, New Zealand, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943055 | ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES Megadyne Medical Products, Inc., Dec 21, 1994 |