Ottawa – Mega Soft Universal (Pediatric) Patient Return Electrode pads, which were designed for patients only up to 22.7kg, have been recalled and removed from healthcare facilities and should NOT be used in any age group. The Mega 2000 and Mega Soft Patient Return Electrode pads listed in Table 2 should only be used on patients aged 12 years and older. Do not use them on neonates, infants and children under the age of 12 years old. Megadyne has received reports of patient and healthcare professional burns during or after surgical procedures in which Mega 2000 and Mega Soft Patient Return Electrode pads were used. Megadyne, in collaboration with Health Canada, has been taking corrective actions to mitigate the potential health risk to healthcare professionals and patients, particularly focusing on children under 12 years of age.
Healthcare professionals are advised of the following:
- Do not use Mega Soft Universal (Pediatric) Patient Return Electrode pads in any age group (see Table 1 in the Products affected section).
- Only use Mega Soft Universal, Mega 2000 or Mega Soft Patient Return Electrode pads on patients aged 12 years and older
Health Canada is working with Megadyne to update the instructions for use (IFU) for all affected product codes. Health Canada continues to assess the risk of thermal injury, and will take appropriate and timely action when new information becomes available.