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U.S. Department of Health and Human Services

Class 1 Device Recall MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode

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  Class 1 Device Recall MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode see related information
Date Initiated by Firm December 08, 2023
Date Posted December 26, 2023
Recall Status1 Open3, Classified
Recall Number Z-0598-2024
Recall Event ID 93597
510(K)Number K233644  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
Code Information UDI-DI 10614559104248 All units within expiry
Recalling Firm/
Manufacturer		 Megadyne Medical Products, Inc.
4545 Creek Rd
Blue Ash OH 45242-2803
For Additional Information Contact
513-337-7300
Manufacturer Reason
for Recall		 Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
FDA Determined
Cause 2		 Under Investigation by firm
Action On December 8, 2023, the firm notified customers via URGENT MEDICAL DEVICE CORRECTION letters. The updated IFU will be made available electronically at www.e-ifu.com. Customers were instructed to share the notification update with all users of Mega Soft Universal and Universal Plus pads, and to take steps to ensure that all personnel using the affected product understand and are reminded that the product is not to be used on patients under 12 years old. If you have additional questions regarding this communication or to report any product complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.
Quantity in Commerce 3,572
Distribution Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Eswatini, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Lebanon, Malaysia, Martinique, Morocco, Netherlands, New Caledonia, Norway, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian , Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam
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.
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