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FDA has classified Avanos Medical's Cortrak*2 EAS recall as Class 1

Avanos Medical called off Cortrak* 2 EAS in response to patient deaths and injuries caused by tube displacements.

The US Food and Drug Administration (FDA) has identified the recall issued by Avanos Medical of Cortrak*2 Ental Access System, (EAS), as an class I recall.

The term "Class I Recall" is a reference to the most difficult of three classes.

Avanos Medical recalls Cortrak*2 EAS following reports of injuries and death due to misplacements of nasogastric or nasoenteric tubes.

The device is designed to assist health professionals to place medical feeding tubes for patients.

However, the wrong positioning of nasogastric or nasal tubes can damage a patient's vocal cords, lungs or trachea, resulting in serious injuries or death.

The company has recalled 629 devices in the US between January 2016 and January 2022.

Avanos Mediacal Cortrak 2 https://classified.citylive.com/index.php?page=user&action=pub_profile&id=824587 The recall notice from the company stated that 60 patients had been injured and 23 died due to incorrect placement in nasogastric tube while using Cortrak* 2 EAS.

Following the recall Avanos Medical will update the labeling of the device. This will include updating instructions on how to use the device and the intended use of Cortrak*2 EAS.

Avanos Mediacal Cortrak 2 The revised guidelines advise users to ensure that the tube has been placed according to the protocols of the institution before to use.

Avanos Mediacal Cortrak 2 Avanos Medical, based in Alpharetta Georgia America is a producer of clinical medical devices. It sells its brands across more than 90 countries.

Cortrak 2 eternal access system Last December, the business entered into an agreement to buy OrthogenRx in an agreement worth $160 million. Avanos Medical closed on the acquisition in January.


Read More: https://splice.com/avanos medicalehxp583
     
 
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