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Avanos Medical has recalled Cortrak*2 EAS in response to reports of injuries and deaths due to tube misplacements.
The US Food and Drug Administration has classified Avanos Medical's Cortrak*2 Entral Access System (EAS), as a Class 1 recall.
A Class I remember is the most serious one of the three classes.
Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and deaths caused by nasoenteric and nasogastric tube misplacements.
Avanos Mediacal Cortrak 2 The device allows health professionals to insert medically-approved feeding tubes into patients.
The wrong placement of Nasogastric tube and nasoenteric tube could cause serious injury , or even death.
Avanos Medical feeding tube Overall, the company recalls 629 devices distributed across the US between April 1st, 2016 and 1 January 2022.
The company also stated in a recall notice that there have been sixty injuries and 23 people that died in 2015 as a result of the incorrect placement of nasogastric feed tubes that were connected to the Cortrak* 2 EAS.
Avanos Medical, following the recall, will revise the device's labelling. Avanos Medical This will include changing the instruction regarding the use and intended usage of Cortrak* 2 EAS.
These revised guidelines direct users to verify tube placement as per the guidelines of the institution's prior to using the tube.
Avanos Medical is based in Alpharetta (Georgia), USA. https://www.productsafety.gov.au/recalls/avanos-medical-australia-pty-ltd-%E2%80%94-mic-gastrostomy-feeding-tubes-expanded-recall It specializes in the manufacturing of medical equipment. https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its Its brands are available in over 90 countries.
Cortrak 2 eternal access system The company entered into a $160m agreement in December of last year to acquire OrthogenRx. https://www.medicalbuyer.co.in/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/ Avanos Medical completed the acquisition on January 20.
My Website: https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its
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