Z-0597-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 3, 2024
- Initiation Date
- December 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,587 ea
Product Description
Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
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.
Distribution Pattern
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
Code Information
UDI-DI 10614559103906 All units within Expiry