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Avanos Medical called off Cortrak* 2 EAS in response to the patient deaths and injuries caused by tube misplacements.
Avanos Medical https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ The US Food and Drug Administration has identified Avanos Medical's Cortrak*2 entry access system (EAS) to be recalled as Class II recall.
A Class I remember is considered to be the most serious of the three classes.
Avanos Medical recalls Cortrak*2 EAS following reports of injuries and death due to the wrong placement of nasogastric and nasoenteric tubes.
Avanos Mediacal Cortrak 2 The device allows skilled health professionals to insert medical feeding tubes in patients.
The wrong placement of Nasogastric or nasoenteric tubes can cause serious injury , or even death.
The company has recalled 629 devices in the US between January 2016 and January 2022.
In the recall announcement the company said that since 2015 there have been 60 injuries and 23 deaths as a result of the incorrect placement or misuse of the Nasogastric feeding tubes while making use of the Cortrak* 2 EAS.
Cortrak 2 eternal access system After the recall, Avanos Medical will update the device's labelling. This includes updating Cortrak*2 EAS's instructions and the intended use.
Avanos Medical These revised guidelines direct users to check the placement of tubes as per the guidelines of the institution's prior use.
Avanos Medical has its headquarters in Alpharetta Georgia. The company markets its recognised brands in over 90 countries.
The company signed an agreement with OrthogenRx to acquire the company in a $160m deal. Avanos Medical completed the acquisition on the 20th of January.
Homepage: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement
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