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

Avanos Medical has recalled Cortrak*2 EAS because of reports of injuries and deaths from tube displacements.

https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding The US Food and Drug Administration (FDA), has designated the recall by Avanos Medical of Cortrak*2 Ental Access System, (EAS), as a class I recall.

The Class 1 recall is the most severe of the three classes.

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

The device allows skilled healthcare professionals to insert medically-approved feeding tubes into patients.

Cortrak 2 eternal access system But, improperly placed nasogastric/nasoenteric pipes could result in damage to the vocal cords and the trachea. This could lead to serious injuries or even death.

https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system In total, the company has been able to recall 629 devices sold across the US between April 1st, 2016 and 1 January 2022.

The recall notice from the company stated that 60 patients had been injured and 23 were killed due to incorrect placement in nasogastric tube while using Cortrak* 2 EAS.

Avanos Medical is updating the labelling on the device after the recall. This will include updating the instructions on how to use the device and the intended use of Cortrak*2 EAS.

Cortrak 2 eternal access system The updated guidelines require that users confirm the position of tubes based on protocols of their institutions prior to using the tubes.

Cortrak 2 eternal access system Avanos Medical is based in Alpharetta (Georgia), USA. Its focus is on the production of medical devices. The company sells its recognized brands across over 90 countries.

Cortrak 2 eternal access system The company came to an agreement with OrthogenRx to purchase the company for $160 million in a deal. Avanos Medical Avanos Medical concluded the acquisition on January 20th.


Read More: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm
     
 
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