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Avanos Medical called off Cortrak* 2 EAS as a result of patient injury and deaths caused by tube malfunctions.
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.
A Class 1 recall is the most serious of three classes.
Avanos Medical feeding tube Avanos Medical pulled Cortrak* 2 EAS off service following patient deaths and injuries due to nasogastric tube misplacements.
The device is intended to assist trained health care personnel place medical tubes for feeding within patients, and provide live information about the tube's location in real-time. placement.
https://www.openstreetmap.org/edit Avanos Mediacal Cortrak 2 However, improper positioning of nasogastric or nasal tubes can damage the vocal cords of patients or trachea, lungs, or vocal cords and cause severe injuries or even death.
The recall affects 629 devices that were sold in the US between February 1st, 2016 until 1 January 2022.
Avanos Mediacal Cortrak 2 The recall notice from the company stated that 60 patients suffered injuries and 23 of them died as a result of the wrong placement of nasogastric tubes when making use of Cortrak* 2 EAS.
Avanos Medical feeding tube Avanos Medical will make the necessary changes to the labeling of the device following the recall. This will include changing the instructions for Cortrak*2 EAS as well as its the intended use.
Users are also directed to verify that tubes have been put in the correct manner according to the guidelines of the institution prior to utilize them.
Avanos Medical is based in Alpharetta (Georgia) America. Its focus is on manufacturing medical devices. It sells its brands in more than 90 different countries.
In December of last year, the company reached an agreement to purchase OrthogenRx in a $160m deal. feeding tube placement Avanos Medical successfully closed the acquisition of OrthogenRx in January.
Homepage: https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://mooc.elte.hu/eportfolios/983717/Home/Cortrak_2_EAS_from_Avanos_Medical_Raises_Safety_of_Patients
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