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

Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and deaths due to tube misplacements.

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

The most severe of the three kinds is the Class I remember.

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

This device can be used to assist trained healthcare professionals to insert medical feeding tubes into patients. Avanos Medical It also provides in real-time information about tube placement.

However, improper placement of nasogastric and nasoenteric tubes could cause damage to a patient's vocal cords and trachea or lungs, resulting in serious injuries or even death.

Avanos Medical feeding tube The company recalls 629 units, which were distributed across the US from April 1st, 2016 to 1 January 2022.

Cortrak 2 eternal access system https://medicaldevices.icij.org/devices/hkg-cortrak-2-enteral-access-system-eas The recall notice from the company stated that 60 patients had been injured and 23 of them died as a result of the wrong placement of nasogastric tubes when using Cortrak* 2 EAS.

Avanos Medical, following the recall, will update the labeling of the device. This includes an update of the instructions on use and intended use of Cortrak* 2 EAS.

Avanos Medical The updated guidelines instruct users to confirm that the tube was installed in accordance with the guidelines of the institution before usage.

Avanos Medical, based in Alpharetta Georgia in the United States, is a manufacturer of medical devices that are clinically proven. Its brands are sold in over 90 countries.

The company signed an agreement to purchase OrthogenRx for $160 million in December. Avanos Medical closed on the acquisition in January.

Cortrak 2 eternal access system
Here's my website: https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/
     
 
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