Enforcement Report - Week of February 27, 2013
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Product Detail
| Product Description | ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation. |
|---|---|
| Recall Number | Z-0827-2013 |
| Classification | Class II |
| Code Info | 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)]. |
| Product Distributed Qty | Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units |
| Reason For Recall | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. |
Event Detail
| Event Id | 64248 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | ConMed Corporation |
| City | Utica |
| State | NY | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-28 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia. |
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