Notes

FDA has identified Avanos Medical's Cortrak*2 EAS recall as Class I

Avanos Medical called off Cortrak* 2 EAS as a result of patient injury and deaths caused by tube misplacements.

The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak* 2 Enteral Access System (EAS) as an I Class recall.

Avanos Medical feeding tube The most severe of the three kinds is a Class I can remember.

Avanos Medical recalls Cortrak*2 EAS following reports of injuries and even death caused by the wrong placement of nasogastric and nasoenteric tubes.

https://en.wikipedia.org/wiki/Avanos_Medical The device is intended to aid healthcare professionals with training to insert medical tubes for feeding inside patients. It also provides live information about the tube's location in real-time. placement.

However, improper placement of the nasogastric/nasoenteric tubs cause severe injuries, or even death.

Avanos Medical Overall, the company recalls 629 devices sold across the US between 1 April 2016 to 1 January 2022.

https://www.hpra.ie/docs/default-source/field-safety-notices/april-2022/v50968_fsn.pdf?sfvrsn=2 According to the recall announcement issued by the company, there were 60 injuries and 23 deaths in 2015 due the misplacement of nasogastric tube feeding tubes during use of the Cortrak* 2 EAS.

https://aacnjournals.org/ajcconline/article/29/1/22/30624/Pneumothoraces-Prevented-With-Use-of Following the recall, Avanos Medical will update the device's labelling. This will include updating Cortrak*2 EAS's instructions and intended uses.

Users are also advised to verify that tubes have been installed in accordance with the protocols of the institution prior to make use of them.

Avanos Medical's headquarters is located in Alpharetta Georgia America. Avanos Mediacal Cortrak 2 They focus on the manufacturing of medical devices. Avanos Medical sells its products in more than 90 different countries.

The company signed a $160m agreement last December to acquire OrthogenRx. https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/ Avanos Medical closed on the acquisition in January.


Homepage: https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html