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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Product Detail

Product Description UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single Use ABC® Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
Recall Number Z-0734-2013
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
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. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.

Event Detail

Event Id 63981
Product Type Devices
Status Ongoing
Recalling Firm ConMed Corporation
City Utica
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-27
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.
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