Megadyne Medical Products, Inc.: Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord

Hazard

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.

Details from the source

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: 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, Po Quantity: 3,572 Lot/code info: UDI-DI 10614559104248 All units within expiry

UPC codes

10614559104248

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.