Notes

Avanos Medical Recalls Cortrak*2 Ental Access System
Avanos Medical (U.S. Food & Drug Administration) has announced that it will be recalling Cortrak*2's enteral access system. This recall was initiated because of injuries to patients and death from misplaced nasoenteric/nasogastric tubes. Avanos Mediacal Cortrak 2 The recall covers 629 devices, that were sold in the United States.

https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ Avanos has promoted its Cortrak*2 Enteral Access System due to its screen-based visualization of the stomach or small bowel, to aid in the proper placement of a medical feeding tube. Patients may suffer injuries to their vocal cords, lungs or trachea if a tube is not correctly placed. According to Avanos Medical's recall announcement, there have been 60 injuries and 23 deaths in patients since 2015 related to misplacement of feeding tubes for the nasogastric system making use of the CORTRAK* 2 Enteral Access System. Avanos Medical Pulmonary failure, pneumothorax (collapsed lung tissue) perforation (a hole in the esophagus or bowel wall) pneumonia, an excess of fluid between the lung and chest cavity (the chest cavity as well as the lungs) have all been among the injuries.

Avanos Medical outlined a plan that would allow users to get updated labels so they are able to confirm the position of nasogastric, nasoenteric and other tubes prior to when they are employed

Avanos is the FDA's second warning about inserting feeding tubes. The FDA sent out a message to parents and healthcare providers concerning the risk of strangulation in the event that feeding tubes are used by children. Two cases of strangulation by a child were reported in 2021. Avanos Medical This was due to a tubing system that was wrapped around the neck of one of the patients.

FDA Recalls Avanos Medical Device

Risk of entering feeding delivery sets

Cortrak* 2 Enteral Access System Product Details

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