ConMed Goldline Hand Controlled With Needle Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 130301A, Steri
FDA device recall Z-1562-2010 · posted 2010-05-10 · Terminated
Recall details
- Recalling firm
- ConMed Electrosurgery
- Reason for recall
- Electrosurgical pencil may remain activated or self activate after power switch is released.
- Action taken
- Customers were notified by letter on March 25, 2010, and were instructed to return all affected devices and to forward the recall information to anyone that may have received the devices to the end user. More information is available by contacting the firm directly at 800-552-0138.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 1400 units (US)
- Distribution
- Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium, Canada, China, Dominican Republic, El Salvador, Japan, Korea, Mexico, Puerto Rico
- Date initiated
- 2010-03-29
- Date posted
- 2010-05-10
- Date terminated
- 2010-09-27
- Location
- Centennial, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SINGLE USE MONOPOLAR HAND CONTROL PENCIL (K791137) | Davol, Inc. | 1979-07-24 |