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Avanos Medical pulled Cortrak*2 EAS from service after receiving reports of deaths and injuries due to tube misplacements.
https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns The US Food and Drug Administration (FDA) has designated the recall by Avanos Medical of Cortrak*2 Ental Access System, (EAS), as a class I recall.
https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Cortrak 2 eternal access system A Class I recall is a reference to the most difficult of three classes.
Cortrak 2 eternal access system Avanos Medical called off Cortrak* 2, EAS after deaths and injuries that resulted from the misplacement of nasogastric tubs.
The device allows health professionals to insert medically-approved feeding tubes into patients.
However, the wrong positioning of the nasogastric or nasoenteric, tubes can cause serious injury or even death.
The company recalls 629 devices sold in the US between January 2016 to January 2022.
Cortrak 2 eternal access system The communication regarding the recall from the company stated that there had been more than 23 patient deaths since 2015 due to the misplacement of the nasogastric feeding tubes when using the Cortrak* 2 EAS.
Avanos Medical is updating the labels on the device following the recall. Cortrak 2 eternal access system This includes updating the instructions on how to use the device as well as intended uses of Cortrak*2 EAS.
https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ These updated guidelines require users to check the placement of tubes according to the institution's protocols prior use.
https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html Avanos Medical is based in Alpharetta (Georgia) America. Its focus is on the production of medical equipment. The company sells its brands in more than 90 different countries.
The company signed a $160m contract in December last year to purchase 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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