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Avanos Medical has recalled Cortrak*2 EAS because of reports of injuries and deaths from tube misplacements.
The US Food and Drug Administration has identified the Cortrak*2 of Avanos Medical's enteral access system (EAS) as a recall as Class II recall.
https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns The most severe of the three kinds is a Class I can remember.
Avanos Medical recalled Cortrak* 2 EAS in the wake of reports of injuries and patient deaths due to nasoenteric or nasogastric tube misplacements.
https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ The device allows skilled health professionals to insert medically-approved feeding tubes into patients.
Incorrect placement of Nasogastric or nasoenteric tubes can result in serious injuries or death.
Avanos Medical The company has recalled 629 devices distributed in the US between January 2016 and January 2022.
The company also stated in a recall announcement that there have been more than 23 patients and 60 injuries who died since 2015 due to the misplacement nasogastric feed tubes when using the Cortrak* 2 EAS.
In the wake of the recall Avanos Medical will update the device's labelling. This includes updating the directions for use as and the intended uses for Cortrak*2 EAS.
Avanos Medical feeding tube The revised guidelines advise users to verify that the tube was set up according to the protocol of their institution prior to its use.
https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement Avanos Medical is based in Alpharetta (Georgia) America. Its focus is on manufacturing medical equipment. Avanos Medical markets its well-known brands across more than 90 countries.
The company signed a $160 million agreement in December of last year to acquire OrthogenRx. Avanos Medical successfully closed the acquisition of OrthogenRx in January.
Here's my website: https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/
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