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Avanos Medical has recalled Cortrak*2 EAS in response to reports of deaths and injuries caused by tube displacements.
The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak* 2 Enteral Access System (EAS) as Class I recall.
A Class I remember is considered to be to be the most important of all three classes.
Avanos Medical recalls Cortrak*2 EAS after reports of injury and even death caused by the wrong placement of nasogastric and nasoenteric tubes.
The device was developed to assist trained health care workers in placing medical feed tubes into patients.
A wrong placement of the Nasogastric tube and nasoenteric tube could result in serious injuries or death.
The company recalls 629 devicesthat were distributed across the US from 1 April 2016 until 1 January 2022.
The company also said in a recall notice that there have been sixty injuries and 23 people killed since 2015 because of the incorrect placement of nasogastric feed tubes that were connected to the Cortrak* 2 EAS.
Cortrak 2 eternal access system Avanos Medical will revise the labelling in the wake of the recall. Avanos Medical This will include updating Cortrak*2 EAS's instructions and expected uses.
These updated guidelines require users to check the placement of tubes according to the institution's protocols prior to use.
Avanos Medical is based in Alpharetta (Georgia), USA. Its focus is on the production of medical devices. Avanos Mediacal Cortrak 2 Avanos Mediacal Cortrak 2 Cortrak 2 eternal access system Avanos Mediacal Cortrak 2 Its brands are available in over 90 countries.
In December of last year the company signed an agreement of $160 million to acquire OrthogenRx. Avanos Medical successfully closed the acquisition of OrthogenRx on 20 January.
https://www.transtats.bts.gov/exit.asp?url=https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical
My Website: https://historyhub.history.gov/external-link.jspa?url=https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
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