Pediatric Patient Return Electrode Recalled for Reported Patient Burns
Megadyne Medical Products is recalling its MEGA SOFT Pediatric Patient Return Electrode due to reports of patient burns during electrosurgical use. Approximately 1,270 units distributed worldwide are affected.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall with reported patient burns. FDA Class I classification indicates the most serious regulatory class, and documented reports of patient injury justify a Critical severity rating.
Plain-English summary
Megadyne Medical Products, Inc. is recalling the MEGA SOFT Pediatric Patient Return Electrode (Model 0840), a reusable electrosurgical device designed for patients weighing 0.8–50 lb (350–22.7 kg). The recall is being conducted due to reports of patient burns associated with use of the device.
The affected device has been distributed worldwide, including to the United States (nationwide and Puerto Rico), Australia, Austria, Bahrain, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, the Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, the United Arab Emirates, and the United Kingdom. Approximately 1,270 units have been distributed bearing Model 0840 with UDI-DI 10614559103395. All lot numbers of this model are affected.
Healthcare facilities and providers currently using the MEGA SOFT Pediatric Patient Return Electrode should immediately discontinue use of the device. Users should contact Megadyne Medical Products, Inc. for information regarding replacement or return of the recalled device.
The recalled product
- Product
- MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.
- Manufacturer
- Megadyne Medical Products, Inc.
- Hazard
- burn-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: 0840
- UDI-DI: 10614559103395
- Lot Number: All distributed lot numbers.
Distribution
Distributed nationwide across the United States.
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