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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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)]. Class II 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. Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units Z-0827-2013
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. 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)]. Class II 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. Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units Z-0826-2013
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