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Avanos Medical pulled Cortrak*2 EAS from service after receiving reports about injuries and deaths caused by tube missing.
Avanos Mediacal Cortrak 2 Avanos Mediacal Cortrak 2 https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2018/1/fda-warns-doctors-of-collapsed-lungs-and-deaths-possibly-linked-to-feeding-tube-placement-devices https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ The US Food and Drug Administration has identified the Cortrak*2 of Avanos Medical's enteral access system (EAS) to be recalled as Class II recall.
Cortrak 2 eternal access system 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 caused by misplacements of nasogastric tubes.
The device is designed to help health care workers to place medical feeding tubes onto patients.
A wrong placement of the Nasogastric or nasoenteric tubes can result in serious injuries or the death of a patient.
The company has recalled 629 devices in the US between January 2016 to January 2022.
According to the recall notice the company has stated that as of 2015, there had been 60 injuries as well as 23 deaths due to the incorrect placement or the use of a Nasogastric feeding tubes while making use of the Cortrak* 2 EAS.
After the recall, Avanos Medical will update the labeling of the device. feeding tube placement This will include changing the instructions for Cortrak*2 EAS as well as its expected uses.
The revised guidelines also direct users to confirm tube placement based on the respective institution's guidelines prior to using.
Avanos Medical has its headquarters in Alpharetta Georgia. The company markets its recognised brands across over 90 countries.
In December of last year Avanos Medical entered into an agreement of $160 million to acquire OrthogenRx. Cortrak 2 eternal access system Avanos Medical completed the acquisition on the 20th of January.
Homepage: https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html
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