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Avanos Medical recalled Cortrak* 2 EAS after reports of injuries and patient deaths due to tube missing.
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.
Avanos Medical A Class I Recall is the most serious kind out of three classes.
Avanos Medical feeding tube Avanos Medical pulled Cortrak* 2 EAS from service after the deaths of patients and injuries related to nasogastric tube misplacements.
Avanos Medical Avanos Medical feeding tube The device is intended to assist medical professionals who are trained to place medical tube feedings within patients, and provide live information about the tube's location in real-time. placement.
However, the incorrect positioning of the nasogastric or nasoenteric tubes could cause serious injury or even death.
The company has been able to recall 629 devices in the US that were sold between April 1st, 2016 and 1 January 2022.
According to the company's recall communication, there were 53 deaths and 60 injuries in 2015 due the incorrect placement of nasogastric feeding tubes in the course of using the Cortrak* 2 EAS.
Avanos Medical Avanos Medical is updating the marking on the device following the recall. Cortrak 2 eternal access system This includes updating the instructions for use as and the intended uses for Cortrak*2 EAS.
Users are also advised to verify that tubes have been placed according to protocols of the institution before they utilize them.
Avanos Medical is based in Alpharetta (Georgia) in the United States. It is a specialist in the production of medical devices. The company sells its brands in over 90 different countries.
The company signed an agreement with OrthogenRx to acquire the company for $160 million in a transaction. Avanos Medical closed the acquisition on the 20th of January.
Cortrak 2 eternal access system
Read More: https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/
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