AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
FDA device recall Z-1074-04 · posted 2004-09-22 · Terminated
Recall details
- Recalling firm
- Encision, Inc.
- Reason for recall
- Electrosurgical tip may break or come off during use.
- Action taken
- Customers were notified beginning 6/15/2004 by phone or visit.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 335 units
- Distribution
- AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.
- Date initiated
- 2004-06-11
- Date posted
- 2004-09-22
- Date terminated
- 2004-11-09
- Location
- Boulder, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD (K912780) | Electroscope, Inc. | 1991-12-30 |