Notes

Avanos Medical Recalls The Cortrak*2 Enteral Access System
According to the U.S. Avanos Medical https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Food & Drug Administration (FDA), Avanos Medical recalls the Cortrak*2 Enteral Access System due to the incorrect placement of nasogastric and nasoenteric tubes has resulted in injuries and patient deaths. The recall currently includes 629 devices distributed across the United States.

Avanos has marketed its Cortrak*2 Enteral Access System due to its interactive display of a patient's stomach , or small bowel, to aid in the proper placement of a medical feeding tube. If a tube is inserted improperly the patient could suffer damage to their vocal cords, lungs or trachea. The recall notification from Avanos Medical states that as of 2015, there have been 60 patient deaths and 23 injuries resulting from incorrect placement of nasogastric feed tubes using the CORTRAK*2 entry access system. There have been numerous incidents, including pneumothorax, respiratory failure, collapsed lung perforation (a hole in the lung's wall or the bowel) as well as the pleural effusion. Cortrak 2 eternal access system This is the excess fluid that forms between your lungs and your chest cavity.

Avanos Medical outlined a plan that would allow users to be updated with labeling so that they are able to confirm the position of nasogastric, nasoenteric , and other tubes prior to them being utilized

Avanos is the FDA's second caution about insertal feeding tubes. In February, the FDA issued a warning for parents and healthcare professionals regarding the risk of strangulation when children are fed by feeding tubes. Two cases of strangulation by a child was reported in 2021. Cortrak 2 eternal access system It was caused by a tubing system that was wrapped around the neck of one of the patients.

FDA Recalls Avanos Medical Device

The potential risks of entering Feeding Delivery sets

Cortrak* 2 Enteral Access System Product Details

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Read More: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/