According to the U.S. Food & Drug Administration (FDA), Avanos Medical is recalling the Cortrak*2 Enteral Access System because misplacement of nasoenteric or nasogastric tubes has resulted in injuries and patient deaths. The recall currently includes 629 devices that were distributed in the United States.
Avanos has marketed the Cortrak*2 Enteral Access System for its on-screen visualization of a patient’s stomach or small bowel, to aid in the proper placement of a medical feeding tube. If a tube is inserted incorrectly, however, patients could experience damage to their vocal cords, lungs, or trachea. According to Avanos Medical’s recall communication, there have been 60 injuries and 23 patient deaths since 2015 related to misplacement of nasogastric feeding tubes while using the CORTRAK* 2 Enteral Access System. Injuries have included respiratory failure, pneumothorax (collapsed lung), perforation (a hole in the wall of the lung, esophagus, or bowel), pneumonia, and pleural effusion (excess fluid between the lungs and chest cavity).
Avanos Medical has described a plan to provide users with updated labeling, to confirm the proper placement of nasogastric and nasoenteric tubes before use
The Avanos warning is the second warning the FDA issued in 2022 about enteral feeding tubes. In February, the FDA issued a warning to healthcare providers and parents about the risk of strangulation when children use feeding tubes. Two child strangulation deaths were reported in 2021, the result of a tubing system that wrapped around a patient’s neck.
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