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According to the U.S. Avanos Medical Food & Drug Administration (FDA), Avanos Medical recalls the Cortrak*2 Enteral Access System because the incorrect placement of nasogastric and nasoenteric tubes has resulted in injuries and patient deaths. https://www.ted.com/profile The recall currently comprises 629 devices which were sold in the United States.
Cortrak 2 eternal access system Avanos marketing its Cortrak*2 Endural Access System is known for its screen-based visualizations of stomachs of patients and small bowels to assist in the placement medical feeding tubes. Patients are at risk of damage to their vocal cords, lungs, or the trachea, if a tube is not correctly placed. Avanos Medical released a recall communication stating that there has been a total of 60 injuries and 23 deaths from mistaken placement, in 2015, because of the CORTRAK*2 Entry Access System. Pulmonary failure, pneumothorax (collapsed lungs) perforation (a hole in the stomach or bowel wall), pneumonia, and excessive fluid that is accumulating between the lung and chest cavity (the chest cavity and the lungs) have all been among the incidents.
Avanos Medical has presented a plan to offer users updated labeling, in order to confirm the correct place of the nasogastric (and the nasoenteric) tubes prior to their use.
The Avanos warning is the second caution the FDA issued in 2022 about tube feeding through the stomach. In February, parents and health professionals were informed by the FDA about the possibility of strangulation of children using feeding tubes. Two cases of child strangulation was reported in 2021. This was due to the tubing system that was placed around the neck of one of the patients.
Avanos Medical FDA Recalls Avanos Medical Device
Risk of entering feed delivery sets
Cortrak* 2 Enteral Access System Product Details
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