Recall Z-0826-2013 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Corporation
ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
| Date | Feb 15, 2013 (initiated Jan 28, 2013) |
| Status | Terminated |
| Reason | Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. |
| Root cause | Equipment maintenance |
| Action | ConMed sent Urgent Device Recall Letters (dated 1/28/13) and Business Reply Forms to all domestic customers via USPS Priority Mail. International notices were sent via FedEx International Priority to the foreign consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and complete Attachment II response form and return it with unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502. Customers were asked to return Attachment II even if they don't have any affected produc |
| Quantity | Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K800617 | HYFRECATOR, #733 Birtcher Corp., May 2, 1980 |