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U.S. Department of Health and Human Services

Class 2 Device Recall MEGADYNE MEDICAL PRODUCTS "12FR" SUCTION COAGULATOR

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 Class 2 Recall
MEGADYNE MEDICAL PRODUCTS "12FR" SUCTION COAGULATOR
see related information
Date Posted March 07, 2014
Recall Status1 Terminated on July 09, 2014
Recall Number Z-1151-2014
Recall Event ID 67641
Premarket Notification
510(K) Number
K072559 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product 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.
Code Information Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018
Recalling Firm/
Manufacturer
Megadyne Medical Products, Inc.
11506 South State Street
Draper, Utah 84020-9453
For Additional Information Contact Ronda K. Magneson
801-576-9669
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Megadyne Medical Product sent an Urgent Medical Device Recall letter dated February 27, 2014, to all affected customers with follow-up phone calls and emails. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed toexamine their inventory immediately to determine if they have any of the affected product. If so, customers were instructed to remove the product from service and contact Megadyne Customer Service at 1-801-576-9669 or 1-800-747-6110 for return authorization and replacement or credit. If customers have distributed any the affected product, they were instructed to immediately contact their distribution points to have the product returned to Megadyne. Customers with questions were instructed to contact Customer Service at 1-800-747-6110 or 1-801-576-9669 or email Regulatory @Megadyne.com. For questions regarding this recall call 801-576-9669.
Quantity in Commerce 494
Distribution USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = MEGADYNE MEDICAL PRODUCTS, INC.
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