Notes

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

Avanos Medical called off Cortrak* 2 EAS in response to patient injury and deaths caused by tube malfunctions.

The US Food and Drug Administration has confirmed Avanos Medical's Cortrak*2 Enal Access System Recall (EAS) in Class I recall.

Avanos Mediacal Cortrak 2 The Class 1 recall is the most severe of the three classes.

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

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

However, improper positioning of nasogastric or nasal tubes could cause damage to the vocal cords of a patient, lungs or trachea which can cause serious injuries or even death.

The company has since removed 629 devices from the US that were sold between 1 April 2016 - 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.

feeding tube placement After the recall, Avanos Medical will update the labeling of the device. This includes the updating of Cortrak*2 EAS's instructions as well as the intended use.

These revised guidelines direct users to check the placement of tubes as per the guidelines of the institution's prior to use.

Avanos Medical is based in Alpharetta (Georgia), USA. feeding tube placement It is a specialist in the manufacturing of medical equipment. Avanos Medical feeding tube The company sells its brands across more than 90 countries.

Avanos Medical feeding tube In December, the company entered into a $160 million deal to purchase OrthogenRx. Avanos Medical concluded the acquisition on the 20th of January.


Here's my website: https://www.transtats.bts.gov/exit.asp?url=https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/