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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Product Detail

Product Description ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, 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-0826-2013
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.