Benzinga - by Vandana Singh, Benzinga Editor.
Johnson & Johnson’s (NYSE:JNJ) medical device subsidiary is pulling its Megadyne Mega Soft Pediatric Patient Return Electrodes following reports of patient burns.
Ethicon’s Megadyne division recalled its Mega Soft and Mega 2000 return electrodes in June 2023. The soft reusable pads are used during electrosurgery.
The electrode aims to minimize the risk of electrical burns by ensuring the current flows safely through the patient’s body and back to the electrosurgical unit, preventing any concentration of electrical energy in one area of the body.
Previously labeled a Class I recall by the FDA, the agency’s most serious category, the move impacted 21,200 devices distributed over two years.
The FDA has said it collected reports of at least 63 injuries, including some third-degree burns, and zero patient deaths.
The recall was expanded in December 2023 to update certain devices’ product labeling and restrict their use to patients 12 years and older, covering around 9,500 units.
Because the pediatric pad is designed for patients between 0.8-50 pounds, predominantly patients under 12, the decision was made to discontinue and recall the 0840 pediatric pad product.
“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,” J&J’s Megadyne said in its announcement.
“The combination of these conditions may be more likely when the pad is used with infants and small children,” the company said.
Between 2018 and today, there have been four reported injuries and no reports of death associated with this product.”
Price Action: JNJ shares are up 0.41% at $150.62 at last check Monday.
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