J&J’s Megadyne Pulls Pediatric Electrodes After Patient Burn Recall

The U.S. Food and Drug Administration has identified Megadyne’s recall of Mega Soft pediatric patient return electrodes as Class I. The recall involves removing devices from where they’re used or sold.
 
Megadyne recalled the electrodes following reports of burn injuries where they were used. Using the affected product can cause serious health consequences for pediatric patients like third-degree burns, scarring, and additional surgeries.
 
The FDA received reports of four injuries, with no reports of death.
 
In its May 8 Urgent Medical Device Recall (Removal) letter, Megadyne urged healthcare providers and facilities to stop using them and immediately return them. To receive credit reimbursement, the product must be returned no later than August 31, 2024.
 
Inventory should be immediately examined to determine if the affected product is on hand. Affected products should then be quarantined with a copy of the recall notice. The issue should then be communicated to relevant operating room or materials management staff. If the product was sent to another facility, that facility must be contacted to arrange return.

More about the Mega Soft electrodes

Megadyne’s pediatric patient return electrodes are soft pads used during electrosurgery for children who weigh between 0.8 and 50 lbs.
 
In electrosurgery, an electric current is used to heat or cut tissue or to stop bleeding. The electric current is generated by an electrosurgical generator and delivered to tissue with a small pen-like attachment. A return electrode pad contacts the skin of the laying patient during use and conducts the electric current from the patient’s tissue back to the electrosurgical unit, or generator, to reduce risk of excessive heating.