Notes

Avanos Medical Recalls Cortrak*2 Enteral Access Systems
Avanos Medical, a U.S. https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview Food and Drug Administration (FDA) company is recalling Cortrak*2 enteral access device because of misplacement of nasoenteric tubes or nasogastric tubs that could have resulted in injuries or even patient deaths. The recall covers 629 devices that were available in the United States.

Avanos markets the Cortrak*2 enteral access device for its visualization of the small bowel and stomach, which assists in the placement of a medical feeding tube. Patients may however be harmed to their vocal cords and their lungs if the tube was not correctly inserted. According to the Avanos Medical recall communication it has been reported that there have been 60 injuries and 23 patient deaths in 2015 due to the misplacement of feeding tubes for the nasogastric system using the CORTRAK* 2 Enteral Access System. Avanos Medical feeding tube There have been a variety of injuries, such as pneumothorax, respiratory failure, collapsed lung, perforation (a opening in the lung's wall or bowel), pneumonia and pleural effusion, which is an excess of fluid between your lungs as well as the chest cavity.

Avanos Medical feeding tube Avanos Medical has described a plan to supply users with current labeling to verify the proper placement of nasogastric and nasoenteric tubes prior to use.

The Avanos warning is the second warning the FDA issued in 2022 concerning tube feeding through the stomach. In February the FDA issued a warning to healthcare providers and parents about the risk of strangulation in children who use feeding tubes. Two cases of child strangulation that involved feeding tubes wrapped around the necks of patients were reported before 2021.

Avanos Medical FDA Recalls Avanos Medical Device

The Risks of Enteral Feeding Delivery Sets

Cortrak* 2 Enteral Access System Product Details

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