Notes

Avanos Medical Announces Recalls of the Cortrak*2 Entry Access System
Avanos Medical (U.S. Cortrak 2 eternal access system Food & Drug Administration) has announced that it is recalling Cortrak*2's Enteral Access System. The recall was announced because of injuries to patients and death from misplaced nasoenteric/nasogastric tubes. The recall covers 629 devices that were sold in the United States.

Cortrak 2 eternal access system Avanos offers its Cortrak*2 enteral access system for its ability to visualize the patient's small bowel and stomach, which helps in the placement of a feeding tube. https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://avanos.com/investor-news/response-to-inquiries-about-the-avanos-cortrak-2-voluntary-field-correction/ However, patients could be harmed to their vocal cords or their lungs if the tube was not properly placed. According to Avanos Medical's recall communication there were 60 incidents of injury and 23 deaths in patients since 2015 related to misplacement of nasogastric feeding tubes while making use of the CORTRAK* 2 Enteral Access System. These injuries include respiratory failure, pneumothorax (collapsed lung), perforation (a hole in the wall of the lung, esophagus, or bowel), pneumonia, and the pleural effusion (excess fluid in the chest cavity and the lungs).

Avanos Medical outlined a plan which would permit patients to get updated labels so they are able to confirm the position of nasogastric, nasoenteric and other tubes prior to them being used

Avanos was the second alert that was issued by the FDA in 2022 about enteral nutrition tubes. The FDA cautioned healthcare professionals and parents of the risk of strangulation among children who use feeding tubes. Two instances of strangulation by children involving feeding tubes wrapped around the necks of patients were reported by 2021.

FDA Recalls Avanos Medical Device

The potential risk associated with enteral feed delivery sets

Cortrak* 2 Enteral Access System Product Details

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