Health product recall

Mega Soft Electrodes

Last updated

Summary

Product
Mega Soft Electrodes
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Mega Soft Universal Patient Return Electrode All lots. 0846 0845
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Megadyne Medical Products Inc

4545 Creek Road, Cincinnati, Ohio, United States, 45242

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74766

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