Notes

Avanos Medical Recalls The Cortrak*2 Enteral Access System
Avanos Medical (U.S. https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ Food and Drug Administration) has announced that it is recalling Cortrak*2's Enteral Access System. https://www.scribd.com/document/383654234/Cortrak-2-Enteral-Access-System-for-Placing-Nasoenteral-Feeding-Tubes-PDF-63499172779717 This recall was initiated due to patient injuries and death from misplaced nasoenteric/nasogastric tubes. The recall covers 629 devices distributed in the United States.

Avanos markets its Cortrak*2 enteral access system that allows its ability to visualize the small bowel as well as stomach, which helps in the placement of a medical feeding tube. Patients can suffer from harm to their vocal cords or trachea, if the tube is inserted in a wrong way. According to the Avanos Medical recall announcement there were 60 incidents of injury and 23 deaths in patients in 2015 due to the misplacement of feeding tubes for the nasogastric system using the CORTRAK* 2 Enteral Access System. Pneumothorax (collapsed lung) or pneumothorax, perforation (a hole or opening in the lung's wall), pneumonia, and Pleural effusion (excess liquid in the lungsand chest cavity) are a few of the incidents.

Avanos Medical describes a plan to change the labeling of its products to ensure proper placement of Nasogastric or Nasoenteric tubes prior to the use

Avanos is the FDA's second warning about insertal feeding tubes. Avanos Medical The FDA issued a caution to parents and healthcare providers regarding the danger of strangulation in the event that feeding tubes are used by children. Cortrak 2 eternal access system Two cases of child strangulation was reported in 2021. This was due to a tubing system placed 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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