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Avanos Medical pulled Cortrak*2 EAS off service following reports of deaths and injuries related to tube misplacements.
The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak*2 Enteral Access System (EAS) as Class I recall.
https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://notes.io/qivDi The most dangerous of the three kinds is the Class I remember.
feeding tube placement Avanos Medical has recalled Cortrak*2 EAS due to reports of deaths or injuries caused by misplacements of nasogastric tubes.
This device can be used to assist health care professionals in placing medically-approved feeding tubes for patients. It also provides in real-time details about the placement of tubes.
However, the wrong positioning of nasogastric or nasal tubes could damage a patient's vocal cords, lungs or trachea which can cause serious injuries or death.
The company has since recalled 629 devices from the US which were distributed between 1 April 2016 - 1 January 2022.
Avanos Medical feeding tube According to the company's recall communication it was reported that there were sixty injuries and 23 deaths in 2015 as a result of the misplacement of nasogastric tube feeding tubes in the course of using the Cortrak* 2 EAS.
Following the recall Avanos Medical will update the labeling of the device. Cortrak 2 eternal access system This includes updating the instructions on use and intended use of Cortrak* 2 EAS.
Avanos Mediacal Cortrak 2 The updated guidelines instruct users to verify that the tube has been placed according to the protocols of their institution prior usage.
Avanos Medical is based in Alpharetta (Georgia) in the United States. It is a specialist in the production of medical devices. Cortrak 2 eternal access system The company's products are distributed in over 90 countries.
Avanos Medical In December of last year the company signed an agreement worth $160 million to acquire OrthogenRx. Avanos Mediacal Cortrak 2 Avanos Medical closed on the acquisition in January.
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