E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/RE
FDA device recall Z-0486-2010 · posted 2009-12-03 · Terminated
Recall details
- Recalling firm
- Megadyne Medical Products, Inc.
- Reason for recall
- Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 324 units
- Distribution
- Worldwide Distribution -- United States (CA, FL, NE, LA, MT, OK, OR, PA, SC and UT) and New Zealand.
- Date initiated
- 2009-10-13
- Date posted
- 2009-12-03
- Date terminated
- 2010-02-17
- Location
- Draper, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| E-Z CLEAN ELECTROSURGICAL ELECTRODE (K081791) | Megadyne Medical Products, Inc. | 2008-10-21 |