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The Avanos Medical Cortrak*2 Entry Access System is designed to aid trained healthcare professionals to insert medical feeding tubes into the small bowel or stomach of patients who are requiring nutrition. The feeding tube has been linked to 23 deaths since 2015.
Cortrak 2 eternal access system There have been numerous reports of injuries and patient deaths after nasoenteric or nasogastric tubes were misplaced while this device is used to aid in their positioning.
The recall will be used to update the information on the device's label, including the instructions and intended uses. The updates instruct users to confirm tube placement in accordance with the guidelines of their institution prior to using the tube to deliver nutrients.
Patients are at risk of suffering severe injuries or death from incorrectly inserted nasogastric and nasoenteric tubes.
According to Avanos Medical's recall announcement there were 60 injuries and 23 deaths due to the misplacement of nasogastric feeding tubes while making use of the CORTRAK* 2 Enteral Access System, since 2015. Cortrak 2 eternal access system There were a variety of adverse events, such as respiratory failure pneumothorax (collapsed lung tissue), perforation (a gap or opening in the wall of the esophagus or bowel) or pneumonia, as well as pleural effusion (excess liquid that has accumulated in the air space between your lungs and your chest cavity).
Avanos Medical sent a field correction notice on the 21st of March 2022 to customers who had utilized the devices between January 2021 & January 2022. https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas The notice included the following guidelines:
Check the position of the nasogastric and nasoenteric and other tubes according with the policies of the institution.
Avanos Medical feeding tube Attach the correct notice in the field regarding the issue to your operator's manual.
Avanos Medical feeding tube Avanos Medical Avanos Med will require you to return the acknowledgement sheet that was included in your emailed notice.
Homepage: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/
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