Class 1 Device Recall MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode

• Date Initiated by Firm: June 17, 2024
• Date Posted: July 03, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2249-2024
• Recall Event ID: 94837
• 510(K)Number: K021077
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
• Code Information: Product Code: 0830; UDI-DI: 10614559101797; Lot Number: All distributed lot numbers. Product code has been discontinued from future production.
• Recalling Firm/ Manufacturer: Megadyne Medical Products, Inc.; 4545 Creek Rd; Blue Ash OH 45242-2803
• For Additional Information Contact: Ethicon Resource Department; 513-337-7300
• Manufacturer Reason for Recall: To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: An URGENT MEDICAL DEVICE CORRECTION letter, dated 6/17/24, was mailed to consignees. Consignees are instructed to share the recall notification with all users of affected devices and confirm their understanding, post a copy of the communication for user awareness, and forward the recall notification to any facility to which product was shipped. The notification reads that Mega Soft and Mega 2000 devices are only to be used for patients 12 years old. The notification also reminds consignees to follow proper cleaning, placement, and setup steps. Consignees are asked to complete and return the provided Business Reply Form by fax to 844-441-2732 or by email to Ethicon8367@sedgwick.com. Customers with any questions about the communication can contact Ethicon at 1-877-384-4266 from Monday through Friday from 8:00 AM EST to 5:00 PM EST. UPDATE: Starting in September 2024, the firm communicated to new and existing consignees reiterating the use of affected devices in patients aged 12 years and older. Additionally, the firm's letter informs consignees that the eIFU of devices indicates that no additional materials should be placed between the patient and Mega Soft pad (example: no sheet).
• Quantity in Commerce: 2584 units
• Distribution: Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, THAILAND, TURKEY, UNITED KINGDOM, UNITED STATES,
• 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