• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

  • Print
  • Share
  • E-mail
-

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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092249. 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. 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. 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. Z-0726-2013
UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, 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. 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. 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. Z-0731-2013
UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, 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. 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. 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. Z-0730-2013
TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092258. 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. 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. 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. Z-0725-2013
UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single Use, Sterile, Rx ONLY --CONMED CORPORATION, UTICA, NY 13502 --- 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. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 12 09 17 X 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. 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. Z-0729-2013
ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL E323246. 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. 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. 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. Z-0724-2013
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., 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. 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. 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. Z-0723-2013
Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION 525 French Road, Utica, NY 13502-5944 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092281. 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. Beginning Lot Code 120628X, Ending Lot Code 120725X. [Lot codes on boxes and packaging contain a lot code in the following form: 120725X where 12 represents the year (2012), 07 represents the month (July), 25 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. 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. Z-0728-2013
ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092258. 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. Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917 X 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. 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. Z-0727-2013
Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, 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. 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. 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. Z-0722-2013
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, 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. 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. 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. Z-0721-2013
Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, 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. 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. 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. Z-0720-2013
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-101-8CS, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL 092250. The Electrolase® Sterile Disposable Electrodes are intended to be used as active RF electrodes for desiccation, fulguration and coagulation. 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. 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. 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. Z-0719-2013
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092250. The Electrolase® Sterile Disposable Electrodes are intended to be used as active RF electrodes for desiccation, fulguration and coagulation. 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. 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. 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. Z-0718-2013
UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation, REF/Catalog No. 139112EXT, 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. 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. 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. Z-0737-2013
UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, 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. 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. 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. Z-0736-2013
UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5944 --- 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. 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. 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. Z-0735-2013
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. 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. 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. Z-0734-2013
UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION, 525 FRENCH RD., 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. 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. 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. Z-0733-2013
UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation, REF/Catalog No. 139105EXT, 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. 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. 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. Z-0732-2013
-
-