• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall MEGADYNE MEGA SOFT Universal Dual Patient Return Electrodesee related information
Date Initiated by FirmDecember 08, 2023
Date PostedDecember 26, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0598-2024
Recall Event ID 93597
510(K)NumberK233644 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductProduct 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
ActionOn 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. 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 3,572
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = GEI
-
-