United States
MEGADYNE™ is initiating a voluntary recall of all MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes. The product is being removed because Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries. Product was distributed in the United States and international markets. Between 2018 and today, there have been 4 reported injuries and no reports of death associated with this product.
The combination of these conditions may be more likely when the pad is used with infants and small children. Because the pediatric pad is designed for patients between 0.8 to 50 pounds, which would be predominantly patients under the age of 12, the decision was made to discontinue and recall the 0840 pediatric pad product.
The Company has decided to discontinue and voluntarily recall the MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode. U.S. (Food and Drug Administration) FDA has been notified of this action
Customers who have MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes should stop using them and return them. The recall includes the following product code, which can be identified by name Pediatric Return Electrode Pad shown on the pad.
The recalled product is MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode, Product Code: 0840, UDI-DI: 10614559103395. Megadyne is notifying global customers and distributors by mail and is arranging for return of impacted product.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Megadyne Medical Products Inc.
Brand name: Ethicon Megadyne
Product recalled: Mega Soft Pediatric Patient Return Electrode
Reason of the recall: Reports of patient burn injuries
FDA Recall date: May 10, 2024
Source:
www.fda.gov
