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FDA has identified Avanos Medical’s Cortrak*2 EAS recall Class I

Avanos Medical has recalled Cortrak*2 EAS because of reports of deaths and injuries caused by tube misplacements.

The US Food and Drug Administration has confirmed the Cortrak*2 of Avanos Medical's Enal Access System Recall (EAS) as Class I recall.

feeding tube placement A Class I recall is the most serious type out of the three classes.

Avanos Medical recalled Cortrak* 2 EAS following incidents of injury and patient deaths caused by nasoenteric and Nasogastric tube misplacements.

The device is intended to help health care workers put medical feed tubes onto patients.

Avanos Mediacal Cortrak 2 But, incorrect placement of nasogastric/nasoenteric tubs can result in severe injuries or even death.

The company has since recalled 629 devices from the US which were distributed between 1 April 2016 - 1 January 2022.

feeding tube placement The communication regarding the recall from the company stated that there have been more than 23 deaths in patients since 2015 due to the misplacement of Nasogastric feeding tubes that were used with the Cortrak* 2 EAS.

Avanos Medical will revise the labelling following the recall. This will include changing the instruction for use and intended uses of Cortrak* 2 EAS.

The updated guidelines also instruct users to confirm tube placement based on the respective institution's protocol prior to use.

Avanos Medical Avanos Medical has its headquarters in Alpharetta Georgia. Avanos Medical sells its products in over 90 different countries.

The company signed an agreement with OrthogenRx to purchase the company in a $160 million deal. Avanos Medical closed on the acquisition in January.


Homepage: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
     
 
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