Notes

Avanos Medical Announces Recalls of the Cortrak*2 Entry Access System
Avanos Medical, a U.S. Food and Drug Administration (FDA) company is recalling Cortrak*2 the enteral access system because of a misplaced nasoenteric tube or nasogastric tubs which could have caused injuries and even deaths of patients. The recall includes 629 devices that were sold in the United States.

Avanos promotes the Cortrak*2 Ental Access System because of its ability to visualize the stomach and small bowel. This permits the installation of an medical feed tube. If the tube is not placed correctly, it can result in damage to the vocal cords, the lungs and trachea. https://www.igj.nl/binaries/igj/documenten/waarschuwingen/2022/05/11/avanos-medical-fca-2022-002---cortrak-2-enteral-access-system-eas/IT2061269+Avanos+FCA-2022-002+-+Cortrak+2+Enteral+Access+System+(EAS).pdf Avanos Medical released a recall announcement stating that there have been sixty incidents and 23 deaths caused by mistaken placement, in 2015, due to the CORTRAK*2 Access System. Cortrak 2 eternal access system These injuries include respiratory failure pneumothorax (collapsed lung) as well as perforation (a hole in the lung's wall, esophagus or bowel) as well as pneumonia. the pleural effusion (excess fluid that has accumulated between the lungs and chest cavity).

Avanos Medical has presented a plan to update users' labeling, in order to confirm the correct positioning of Nasogastric (and the nasoenteric) tubes prior to their use.

The Avanos warning is the second caution the FDA issued in 2022 about the use of enteral feeding tubes. In February the FDA issued a warning to health professionals as well as parents about the possibility of strangulation when children use feeding tubes. Two instances of strangulation in children with feeding tubes securing the necks of patients have been reported before 2021.

Cortrak 2 eternal access system FDA Recalls Avanos Medical Device

Potential Risks of Enteral Feeding Delivery Sets

Cortrak* 2 Enteral Access System Product Details

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Read More: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause