Product Wiki · Recalls · Health Canada — Medical Devices

Mega Soft Electrodes — recall 74766

Health Canada — Medical Devices · Canada · 2023-12-20 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
74766
Date of alert
2023-12-20
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
General and plastic surgery
Product type
Medical devices
Reported risk: Megadyne has received reports of patient burns identified after surgical procedures in which mega soft pads were used. Megadyne is taking this corrective action to mitigate the potential risk to health in the population of children under 12 years of age. We have conducted a thorough investigation, and have not identified any design or manufacturing defects, nor have we determined definitive root cause for the reports. Recall Start Date: December 12, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/mega-soft-electrodes

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