Megadyne Medical Products, Inc.: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1

Hazard

Reports of patient burns.

Details from the source

Reason for recall: Reports of patient burns. Distribution: Worldwide distribution. US nationwide including Puerto Rico; Australia, Austria, Bahrain, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, the Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates, and United Kingdom. Quantity: 1270 Lot/code info: Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.

UPC codes

10614559103395

Source

Official record: FDA (Device enforcement) ↗

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