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Avanos Medical called off Cortrak* 2 EAS in response to the patient injury and deaths caused by tube displacements.
The US Food and Drug Administration has confirmed Avanos Medical's Cortrak*2 enal Access System Recall (EAS) in a Class I recall.
A Class I can remember is considered to be to be the most important of the three classes.
Avanos Medical called off Cortrak*2, EAS, following injuries and deaths resulting from misplacements of nasogastric tubs.
The device allows skilled healthcare personnel to place medical feeding tubes inside patients.
https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system However, incorrectly installed nasogastric/nasoenteric pipe could cause harm to vocal cords and the trachea. https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ This could lead to grave injuries or even death.
The recall covers 629 devices sold in the US between 1 February 2016 and 1 January 2022.
Avanos Medical feeding tube The recall communication from the company added that there had been more than 23 patient deaths since 2015 due to the misplacement or misplacement nasogastric feeding tubes while using the Cortrak* 2 EAS.
Avanos Medical, following the recall, will revise the device's labelling. This will include updated instructions on how to use the device and the intended use of the Cortrak*2 EAS.
https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 These revised guidelines direct users to verify tube placement in accordance with the protocol of the institution's prior to use.
Avanos Mediacal Cortrak 2 Avanos Medical is based in Alpharetta (Georgia), USA. It specializes in the manufacturing of medical devices. It sells its brands in more than 90 different countries.
feeding tube placement The company came to an agreement with OrthogenRx to acquire the company in a $160m transaction. Avanos Medical successfully closed the acquisition of OrthogenRx in January.
Homepage: https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns
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