Rocker Switch Electrosurgical Pencil with Holster
FDA device recall Z-0784-06 · posted 2006-04-19 · Terminated
Recall details
- Recalling firm
- Megadyne Medical Products, Inc
- Reason for recall
- Surgical device packaging may be damaged and may compromise sterility.
- Action taken
- Consignees were notified by letter on 04/06/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 3,399 units
- Distribution
- Nationwide, including one VA facility in OH. No military consignees. Foreign distribution to France, India, Ireland, Japan, South Korea, Malaysia, Poland, UK.
- Date initiated
- 2006-04-06
- Date posted
- 2006-04-19
- Date terminated
- 2006-08-03
- 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 |
|---|---|---|
| PENCIL (K965054) | Megadyne Medical Products, Inc. | 1997-01-24 |