Notes

FDA announces the Cortrak*2 of Avanos Medical's EAS Recall Class I

Avanos Medical recalls Cortrak*2 EAS after reports of injury and deaths due to tube incorrect placement.

The US Food and Drug Administration has identified Avanos Medical’s Cortrak*2 enteral access system (EAS) to be recalled as Class II recall.

The most severe of the three types is a Class I remember.

Avanos Medical called off Cortrak* 2, EAS, due to deaths and injuries resulting from the misplacement of tubs for nasogastric surgery.

https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Cortrak 2 eternal access system The device was designed to aid trained health professionals in putting medical feed tubes for patients.

But, the incorrect placement of nasogastric or nasoenteric tubes could cause damage to the vocal cords of a patient, lungs or trachea, resulting in serious injury or even death.

The company has now recalled 629 devices from the US which were distributed between April 1, 2016 and 1 January 2022.

According to the company's recall notice it was reported that there were 53 deaths and 60 injuries in 2015 due the misplacement of nasogastric tube feeding tubes when using the Cortrak* 2 EAS.

Avanos Medical, following the recall, will be updating the device’s labelling. https://www.aboutlawsuits.com/feeding-tube-system-deaths-138564/ This includes updating the directions on how to use the device as well as the intended use of Cortrak*2 EAS.

The updated guidelines require that users confirm the placement of tubes based on protocols of their institutions before making use of the tubes.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its The headquarters are located in Alpharetta, Georgia, US, Avanos Medical focuses on the production of medical devices that are clinically proven. feeding tube placement Avanos Medical's well-known brands are available in over 90 countries.

Cortrak 2 eternal access system Avanos Mediacal Cortrak 2 The company signed an agreement to purchase OrthogenRx for $160 million in December. https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html Avanos Medical completed the acquisition on the 20th of January.


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