Notes

FDA confirms the Avanos Medical Cortrak* 2 EAS recall as Class I

Avanos Medical recalled Cortrak* 2 EAS following reports of injuries and patient deaths due to tube misplacements.

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

Avanos Medical feeding tube feeding tube placement A Class 1 recall is the most serious among three classes.

Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths from nasogastric tube misplacements.

The device is able to assist health professionals with the placement of medically-approved feeding tubes for patients. Avanos Medical feeding tube It also provides real-time information about tube placement.

However, the wrong placement of the nasogastric or nasoenteric tubes could cause severe injury or death.

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

The recall notice from the company stated that 60 patients were injured and 23 died due to misplacement in nasogastric tubes while making use of Cortrak* 2 EAS.

Avanos Medical will make the needed changes to the labeling of the device following the recall. This will include updating instructions regarding the use and intended uses of the Cortrak*2 EAS.

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

Avanos Medical's headquarters is located in Alpharetta Georgia USA. They focus on the manufacturing of medical equipment. The company sells its brands across more than 90 countries.

Last December the company signed a $160 million deal to acquire OrthogenRx. Avanos Medical closed the acquisition on January 20th.

Avanos Mediacal Cortrak 2
Here's my website: https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/