Health product recall

Mega Soft Universal Patient Return Electrode

Last updated

Summary

Product
Mega Soft Universal Patient Return Electrode
Issue
Medical devices - Performance
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.

0840

Issue

Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used.  A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries.  The combination of these conditions may be more likely when the pad is used with infants and small children.

Recall Start Date: May 8, 2024

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-75521

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