Notes

Avanos is facing an FDA Class I recall after 23 deaths related to the device
Avanos Medical Cortrak*2 Enteral Access System was designed to aid medical professionals who are trained to insert medical feeding tubes in the stomach or small bowel of patients who need to be fed through the tube. In 2015, however, 23 people have died from complications related to feeding tube.

There have been numerous reports of injury and death in patients who have lost their nasogastric tube.

This recall will be used to modify the labeling of the device, including the instructions and intended uses. The update instructs users to confirm that the tube is set up according to the institution's protocols prior to using the tube for nutritional delivery.

Avanos Medical Cortrak 2 eternal access system Patients could suffer serious injury or even die if a nasogastric tube or nasoenteric tub has been incorrectly inserted.

Avanos Medical According to Avanos Medical's recall announcement there have been 60 injuries and 23 patient deaths related to the incorrect placement of nasogastric feed tubes when making use of the CORTRAK* 2 Enteral Access System, since 2015. Respiratory failure, pneumothorax perforation (a hole, in the wall, or stomach) and pneumonia were all reported.

Avanos Medical issued on March 21, 2022, a field correction notice to its customers who use these devices between January 20,21 and January 20,22. Avanos Medical feeding tube The notice included the following guidelines:

Install nasogastric tubs or nasoenteric tub in accordance with the institution's policies.
Avanos Medical feeding tube Attach the corrective notice in the field in the operator's manual.
Send the acknowledgement form with the notice emailed to Avanos Medical
Read More: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/