Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230.
FDA device recall Z-0144-04 · posted 2003-11-19 · Terminated
Recall details
- Recalling firm
- ConMed Electrosurgery
- Reason for recall
- The Hyfrecator 2000 units were released without documented adherence to their voltage output specification.
- Action taken
- All customers were notified by certified letter on 9/15/03. Mailing to the Phillipines by registered mail also on 9/15/03. Firm requests that the units be returned for testing or the replacement with another unit.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 10 units
- Distribution
- Units were distributed to CA, CT,IL and ME. International distribution to Phillipines.
- Date initiated
- 2003-09-15
- Date posted
- 2003-11-19
- Date terminated
- 2004-07-01
- Location
- Centennial, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYFRECATOR 2000 (K970493) | Aspen Labs | 1997-04-30 |