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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

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.
Recall Number Z-1151-2014
Classification Class II
Code Info Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018
Product Distributed Qty 494
Reason For Recall 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.

Event Detail

Event Id 67641
Product Type Devices
Status Ongoing
Recalling Firm Megadyne Medical Products, Inc.
City Draper
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.