Recall Z-0486-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Megadyne Medical Products, Inc.
E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenev
| Date | Dec 3, 2009 (initiated Oct 13, 2009) |
| Status | Terminated |
| Reason | Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07. |
| Root cause | Error in labeling |
| Action | A notification letter dated October 13, 2009 was sent to the first level consignees. Consignees were instructed to examine their stock, remove affected product and contact Megadyne Customer Service at 1-800-747-6110 (United States) or 1-801-576-9669 for product return instructions. |
| Quantity | 324 units |
| Distribution | Worldwide Distribution -- United States (CA, FL, NE, LA, MT, OK, OR, PA, SC and UT) and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE Megadyne Medical Products, Inc., Oct 21, 2008 |