| | Class 2 Recall
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT |  |
| Date Posted |
February 15, 2013 |
| Recall Number |
Z-0827-2013 |
| Product |
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA.
Intended to be used as active RF electrodes for desiccation, fulguration and coagulation. |
| Code Information |
Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
|
Recalling Firm/
Manufacturer |
ConMed Corporation
525 French Road
Utica, New York 13502 |
| Consumer Instructions |
No consumer action necessary |
Reason for
Recall |
Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
|
| 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 product. For questions regarding this recall call 315-624-3533. |
| Quantity in Commerce |
Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units |
| Distribution |
Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia. |
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