The Food and Drug Administration (FDA) on Thursday warned that patients could suffer serious injuries or health consequences, including death, from the use of recalled electrode pads.
Megadyne issued a recall in May of its Megadyne Mega Soft Pediatric Patient Return Electrodes after four patients suffered burn injuries during procedures that used the devices. No deaths were reported, the FDA said, but continued use of the products could result in third-degree burns, scarring or additional surgeries.
The pads, used to conduct electric current from the patient’s tissue during electrosurgery, are for children who weigh between 0.8 and 50 pounds, according to the recall. They are designed to reduce the risk of excessive heating of the patient’s tissue.
The FDA categorizes this as a Class I recall, its most serious type, and advises all health care providers and facilities that use the Megadyne pads to stop using them immediately and send them back to the company.
The devices carry product code 0840 and a unique device identifier (UDI) of 10614559103395.
Questions should be directed to the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).
