FDA-Device2014-03-19Class II
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or
Megadyne Medical Products, Inc.
Hazard
Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.
Sold states
USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.
Affected count
494
Manufactured in
11506 South State Street, N/A, Draper, UT, United States
Products
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1151-2014Don't want to check this manually?
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