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Avanos Medical recalled Cortrak* 2 EAS following incidents of injury and deaths due to tube missing.
The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak* 2 Enteral Access System (EAS) as an I Class recall.
The most severe of the three kinds is a Class I recall.
Cortrak 2 eternal access system Avanos Medical pulled Cortrak* 2 EAS from service after patient deaths and injuries due to nasogastric tube misplacements.
The device allows health professionals to insert medically-approved feeding tubes into patients.
Avanos Medical But, the incorrect positioning of the nasogastric or nasoenteric tube could cause serious injury or even death.
The recall affects 629 devices sold in the US between 1 February 2016 to 1 January 2022.
According to the recall notice, the company stated that since 2015 there have been 60 injuries as well as 23 deaths as a result of the misplacement or misuse of the Nasogastric feeding tubes when making use of the Cortrak* 2 EAS.
After the recall Avanos Medical will update the labeling of the device. Cortrak 2 eternal access system Cortrak 2 eternal access system This includes updating Cortrak*2 EAS's instructions and expected uses.
The updated guidelines instruct users to check the placement of tubes in accordance with the protocol of the institution's prior use.
Avanos Medical has its headquarters in Alpharetta Georgia. It sells its brands in more than 90 different countries.
The company entered into a $160m agreement last December to acquire OrthogenRx. Avanos Medical closed on the acquisition in January.
Avanos Medical feeding tube Avanos Medical feeding tube
My Website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
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