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Avanos Medical pulled Cortrak*2 EAS from service after receiving reports of injuries and deaths caused by tube misplacements.
The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak* 2 Enteral Access System (EAS) as a Class I recall.
The most dangerous of the three types is a Class I can remember.
Avanos Medical recalled Cortrak* 2 EAS in the wake of reports of injuries and patient deaths due to nasoenteric or Nasogastric tube malfunctions.
The device was created to assist health care professionals when placing medical feed tubes into patients.
Avanos Medical But, improperly installed nasogastric/nasoenteric pipe could cause harm to the vocal cords and trachea. This could lead to serious injuries or even death.
The recall covers 629 devices sold in the US between February 1st, 2016 until 1 January 2022.
https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Cortrak 2 eternal access system According to the recall announcement issued by the company, there were sixty injuries and 23 deaths during 2015 because of the misplacement of nasogastric tube feeding tubes when using the Cortrak* 2 EAS.
Following the recall, Avanos Medical will update the labeling of the device. This includes the updating of Cortrak*2 EAS's instructions as well as expected uses.
Cortrak 2 eternal access system Users should also confirm that the tubes have been installed in accordance with the protocols of the institution before they utilize them.
Avanos Medical's headquarters are located in Alpharetta Georgia America. Avanos Medical feeding tube They specialize in manufacturing medical equipment. Its brands are sold in more than 90 countries.
Cortrak 2 eternal access system The company signed a $160m agreement in December of last year to acquire OrthogenRx. Avanos Medical closed on the acquisition in January.
Avanos Medical feeding tube
Here's my website: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its
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