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Avanos Medical pulled Cortrak*2 EAS from service after receiving reports of deaths and injuries related to tube missing.
The US Food and Drug Administration (FDA) has designated the recall by Avanos Medical of Cortrak*2 Ental Access System, (EAS), as an I class recall.
A Class I Recall is the most serious kind of the three classes.
Avanos Medical recalls Cortrak*2 EAS after reports of injury and even death caused by incorrect placements of nasogastric or nasal tubes.
https://www.hcplive.com/view/fda-issues-letter-to-health-care-providers-about-pneumothorax-events The device was created to assist trained health care workers in placing medical feed tubes in patients.
However, incorrectly placed nasogastric/nasoenteric pipes could result in damage to the vocal cords and trachea. This could lead to serious injuries or even death.
Cortrak 2 eternal access system The company has recalled 629 devices distributed throughout the US between January 2016 and January 2022.
According to the recall notice, the company stated that as of 2015, there had been more than 60 injuries and 23 deaths due to the incorrect placement or the use of a nasogastric feeding tube while making use of the Cortrak* 2 EAS.
Avanos Medical, following the recall, will revise the labeling of the device. This will include changing the instruction for use and intended uses of Cortrak* 2 EAS.
The updated guidelines instruct users to check the placement of tubes as per the guidelines of the institution's prior to using the tube.
The headquarters of Avanos Medical is in Alpharetta Georgia USA. Avanos Medical feeding tube They are a specialist in the production of medical devices. Avanos Medical markets its well-known brands across more than 90 countries.
feeding tube placement Avanos Medical feeding tube The company signed a $160m agreement last December to acquire OrthogenRx. Avanos Medical closed on the acquisition in January.
Homepage: https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its
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