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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 1,270
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
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