Notes

FDA has declared Avanos Medical's Cortrak*2 EAS Recall Class I

Avanos Medical recalls Cortrak*2 EAS in the wake of reports of injury and death due to 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.

A Class 1 recall is the most serious of the three classes.

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

The device is designed to aid health care professionals place medical feeding tubes for patients.

https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system However, the wrong placement of the nasogastric or nasoenteric tube could result in severe injuries or even death.

Avanos Medical feeding tube Overall, the company has recalls 629 devices sold in the US between 1 April 2016 and 1 January 2022.

The recall notification from the company said that 60 patients had been injured and 23 died due to the wrong placement of nasogastric tubes when making use of Cortrak* 2 EAS.

Avanos Medical is updating the marking on the device following the recall. This will include updating the instructions and intended applications of Cortrak* 2 EAS.

The revised guidelines also direct users to ensure that the tube is placed in accordance with the institution's protocol prior to use.

Avanos Medical has its headquarters in Alpharetta Georgia. Avanos Medical has over 90 markets that are branded with its brands.

The company signed a $160 million contract in December last year to purchase OrthogenRx. Cortrak 2 eternal access system Avanos Medical feeding tube Avanos Medical concluded the acquisition on January 20th.

Avanos Medical feeding tube Avanos Medical feeding tube
Read More: https://www.nutritioncare.org/News/General_News/Nasoenteric_Feeding_Tube_Placement_and_Verification/