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

Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries and deaths caused by tube misplacements.

https://www.newsbreak.com/news/2607393691988/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i The US Food and Drug Administration has identified Avanos Medical's Cortrak*2 entry access system (EAS) to be recalled as an Class II recall.

Cortrak 2 eternal access system The most severe of the three kinds is the Class I remember.

Avanos Medical pulled Cortrak* 2 EAS from service after death and injuries of patients due to nasogastric tube misplacements.

Avanos Medical The device allows trained healthcare professionals to insert medically-approved feeding tubes into patients.

But, improperly installed nasogastric/nasoenteric pipe can cause damage to vocal cords or the trachea. This can lead to grave injuries or even death.

The company has recalled 629 devices from the US that were sold between April 1st, 2016 and 1 January 2022.

feeding tube placement According to the recall notice, the company stated that in the year 2015, there have been 60 injuries and 23 deaths due to the misplacement or misuse of the nasogastric feeding tube while making use of the Cortrak* 2 EAS.

Avanos Mediacal Cortrak 2 Avanos Medical, following the recall, will revise the labeling of the device. This will include updating the instructions for use and intended uses of Cortrak* 2 EAS.

The updated guidelines also instruct users to ensure that the tube is placed based on the respective institution's protocol prior to use.

Avanos Medical, based in Alpharetta Georgia in the United States is a producer of medical devices for clinical use. The brand's name is accessible in over 90 countries.

In December, the company entered into an agreement of $160 million to purchase OrthogenRx. Avanos Medical closed the acquisition on the 20th of January.


Website: https://prais.paho.org/es/avanos-medical-recalls-cortrak2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm/
     
 
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