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FDA has classified Avanos Medical's Cortrak*2 EAS recall as Class 1.

Avanos Medical recalls Cortrak*2 EAS in the wake of reports of injury and even death caused by tube malfunctions.

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

The most dangerous of the three types is the Class I recall.

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

The device is intended to help medical professionals who are trained to place medical tube feedings in patients and offer live information about the tube's location in real-time. placement.

Cortrak 2 eternal access system However, improper positioning of nasogastric or nasal tubes could cause damage to the vocal cords of patients, lungs or trachea which can cause serious injury or even death.

https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 In total, the company has recalled 629 devices that were sold in the US between April 1st, 2016 to 1 January 2022.

According to the recall announcement issued by the company the company's recall communication, there were 60 injuries and 23 deaths in 2015 due the incorrect placement of nasogastric feeding tubes during use of the Cortrak* 2 EAS.

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

Avanos Medical feeding tube The new guidelines direct users to verify that the tube was installed in accordance with the guidelines of the institution before to use.

The headquarters of Avanos Medical is in Alpharetta Georgia USA. They focus on the manufacturing of medical equipment. Avanos Medical has over 90 markets for its recognized brands.

The company reached an agreement with OrthogenRx to purchase the company for $160 million in a transaction. Avanos Medical concluded the acquisition on the 20th of January.

https://www.medscape.com/viewarticle/891200 https://www.hpra.ie/docs/default-source/field-safety-notices/april-2022/v50968_fsn.pdf?sfvrsn=2 feeding tube placement
Homepage: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
     
 
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