Devices

Device Recall MEGADYNE MEDICAL PRODUCTS "12FR" SUCTION COAGULATOR

Model / Serial
Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.
Product Description
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.
Manufacturer
Megadyne Medical Products, Inc.
1 Event
- Recall of Device Recall MEGADYNE MEDICAL PRODUCTS "12FR" SUCTION COAGULATOR

Manufacturer

Megadyne Medical Products, Inc.

Manufacturer Address
Megadyne Medical Products, Inc., 11506 South State Street, Draper UT 84020-9453
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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