FDA tags Megadyne paediatric return electrode recall as Class I [Yahoo! Finance]
Johnson & Johnson (JNJ)
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Source: Yahoo! Finance
Class I indicates the agency's most serious designation for a recall, meaning continued use of the products, without actions being taken, could cause serious injury or death. A medical device subsidiary of Johnson and Johnson (J&J), Megadyne discontinued its Mega Soft and Mega 2000 paediatric return electrodes last month. The device was part of a line of products recalled in July 2023, and later expanded in December 2023. The flat and reusable pads are placed on the skin of the patient undergoing electrosurgery to help dissipate excessive heating, conducting the electric current from the patient back to the generator or electrosurgical unit. The paediatric version is for use on children who weigh between 0.8lb and 50lb. The recall is due to reports of patient burn injuries whilst using the device. Health consequences include third-degree burns, scarring, and the need for additional surgeries. There have been four injuries due to the device. No deaths have been reported. Acc
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