Mega Soft Electrodes
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Mega Soft Universal Patient Return Electrode |
All lots. |
0846 |
Mega Soft Universal Plus Patient Return Electrode |
All lots. |
0847 |
Mega Soft Dual Universal Plus Patient Return Electrode |
All lots. |
0848 |
Issue
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
Additional information
Details
Megadyne Medical Products Inc
4545 Creek Road, Cincinnati, Ohio, United States, 45242
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