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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-01080-1
Product Name/Description	MEGADYNE MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes MEGADYNE MEGA SOFT Universal Patient Return Electrode - PC: 0845 MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode - PC: 0846 MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode - PC: 0847 MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode - PC: 0848 ARTG 295480 (Johnson & Johnson Medical Pty Ltd - Electrosurgical diathermy system return electrode, reusable)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	14/12/2023
Responsible Entity	Johnson & Johnson Medical Pty Ltd
Reason/Issue	Megadyne Medical Products, Inc. (“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. Megadyne are initiating updates to the Instructions for Use (IFU) and product labelling to reflect that these product codes should not be used in patients under 12 years old. Users should continue to follow the current Mega Soft Instructions for Use (IFU) except for this new limitation in population of intended use.
Recall Action	Product Defect Correction
Recall Action Instructions	Megadyne are initiating updates to the Instructions for Use (IFU) and product labelling to reflect that these product codes should not be used in patients under 12 years old. Users should continue to follow the current Mega Soft Instructions for Use (IFU) except for this new limitation in population of intended use. Health care practitioners who have used Mega Soft pads during patient procedures should follow those patients post-operatively in the usual manner. This action has been closed out on 15/3/2024.
Contact Information	02 9815 4000 - Johnson & Johnson Medical Pty Ltd