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U.S. Department of Health and Human Services

Class 1 Device Recall Patient Return Electrode Pad

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  Class 1 Device Recall Patient Return Electrode Pad see related information
Date Initiated by Firm June 01, 2023
Date Posted June 30, 2023
Recall Status1 Open3, Classified
Recall Number Z-2001-2023
Recall Event ID 92409
510(K)Number K133726  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Code Information Model No. 0846; UDI-DI: 10614559104248; All Units.
Recalling Firm/
Megadyne Medical Products, Inc.
4545 Creek Rd
Blue Ash OH 45242-2803
For Additional Information Contact Ethicon Resource Department
Manufacturer Reason
for Recall
Firm has received reports of patient burns in surgical procedures where device was used.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm distributed a recall notification by mail starting 06/01/2023. Customers are to provide the notice to all users of MEGADYNE MEGA SOFT and MEGA 2000 Reusable Patient Return Electrodes that participate in the cleaning, setup, and operation of affected devices. Megadyne has been made aware of 63 reports of serious patient burns since April 2018. The firm has attributed the incidence of burns to some instances that the Mega Soft Pad Instructions For Use were not being properly followed. Devices must be thoroughly rinsed after cleaning to ensure any cleaning residue is removed. Customers are asked to distribute the recall notification to all users, confirm that personnel are following the Instructions For Use, and post the provided informational attachments near the OR for staff member reference. If devices have been further distributed customers are to share the provided recall notice. Completed Business Reply Forms are to be faxed to Sedgwich at 888-214-7430 or emailed Ethicon5627@sedgwick.com. Any questions about the Business Reply Form can be made by phone to 888-843-0254 (Reference Event 5627). Any questions about this recall or to report a complaint can be made by phone to 1-877-384-4266, Monday thru Friday from 8:00 AM to 5:00 PM. Medical Engagement can be requested at https://www.jnjmedtech.com/mir.
Quantity in Commerce 21,100 units
Distribution Distributed US Nationwide.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = MEGADYNE MEDICAL PRODUCTS, INC.