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

Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and patient deaths caused by tube misplacements.

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

Cortrak 2 eternal access system A Class I remember is the most serious one out of three classes.

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

The device is designed to aid trained health care personnel place medical feeding tubes in patients and offer the most current information about tube placement.

However, incorrectly placed nasogastric/nasoenteric tubes could cause harm to the vocal cords and trachea. Cortrak 2 eternal access system This could result in severe injuries, or even death.

Overall, the company been able to recall 629 devices distributed 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.

In the wake of the recall, Avanos Medical will update the labeling of the device. This will include updating instructions regarding the use and intended uses of Cortrak*2 EAS.

Revisioned guidelines require that users confirm the placement of tubes in accordance with protocols of their institutions before making use of them.

https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ Avanos Medical has its headquarters in Alpharetta Georgia. Avanos Medical feeding tube The company's products are distributed in over 90 countries.

In December of last year, the company reached an agreement to purchase OrthogenRx with a $160m deal. Avanos Medical successfully closed the acquisition of OrthogenRx in January.


Here's my website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
     
 
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