FDAFDA · Food and drugs·Recall number Z-1151-2014
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.
Published March 19, 2014 · Recall initiated: February 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Megadyne Medical Products, Inc.
- Distributor
- USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.
- Lot
- Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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