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FDA classifies Avanos Medical's Cortrak*2 EAS recall as Class 1

Avanos Medical called off Cortrak* 2 EAS as a result of patient deaths and injuries caused by tube misplacements.

Avanos Mediacal Cortrak 2 The US Food and Drug Administration has classified Avanos Medical's Cortrak*2 Entral Access System (EAS), as a Class 1 recall.

Avanos Mediacal Cortrak 2 A Class I can remember is considered to be the most serious out of all three classes.

Avanos Medical called off Cortrak*2, EAS, after deaths and injuries that resulted from the misplacement of nasogastric tubs.

The device is intended to assist trained health care personnel place medical tubes for feeding in patients and offer the most current information about tube placement.

But, incorrect placement of the nasogastric/nasoenteric tubs cause severe injuries, or even death.

The recall covers 629 devices sold in the US between February 1st, 2016 to 1 January 2022.

In the recall announcement the company has stated that as of 2015, there had been more than 60 injuries and 23 deaths as a result of the improper placement or misuse of the nasogastric feeding tube while making use of the Cortrak* 2 EAS.

https://mooc.elte.hu/eportfolios/1772058/Home/Avanos_Medical_faces_Class_I_recalls_in_relation_to_23_deaths_resulting_from_the_feeding_tube_system_ Avanos Medical is updating the marking on the device following the recall. This includes updating the instructions and intended applications of Cortrak* 2 EAS.

Avanos Medical These revised guidelines direct users to check the placement of tubes in accordance with the protocol of the institution's prior to using the tube.

https://canvas.instructure.com/eportfolios/1604756/Home/Cortrak_2_EAS_from_Avanos_Medical_Raises_Patients_Safety_Bespins Avanos Medical has its headquarters in Alpharetta Georgia. The company markets its recognised brands in more than 90 countries.

In December of last year Avanos Medical entered into an agreement of $160 million to acquire OrthogenRx. Avanos Medical completed the acquisition on January 20.

Avanos Medical
Read More: https://mooc.elte.hu/eportfolios/1772058/Home/Avanos_Medical_faces_Class_I_recalls_in_relation_to_23_deaths_resulting_from_the_feeding_tube_system_
     
 
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