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Avanos Medical recalled Cortrak* 2 EAS after reports of injuries and patient deaths due to tube misplacements.
The US Food and Drug Administration (FDA) has declared the recall of Avanos Medical of Cortrak*2 Ental Access System, (EAS) as a class I recall.
Cortrak 2 eternal access system The most serious of the three types is a Class I can remember.
https://mooc.elte.hu/eportfolios/2721907/Home/Avanos_Recalls_FDA_Class_II_After_23_deaths_attributed_to_the_device Avanos Medical Avanos Medical pulled Cortrak* 2 EAS off service following patient deaths and injuries due to nasogastric tubes misplacements.
The device allows healthcare personnel to place medical feeding tubes inside patients.
However, the wrong placement of nasogastric or nasoenteric tubes could damage a patient's vocal cords or trachea, lungs, or vocal cords and cause severe injuries or even death.
The company is recalling 629 units, which were made available across the US between 1 April 2016 until 1 January 2022.
The company also stated in a recall communication that there had been more than 23 patients and 60 injuries who died since 2015 due to the misplacement nasogastric feed tubes in the Cortrak* 2 EAS.
Avanos Medical is updating the labels on the device following the recall. This includes the updating of Cortrak*2 EAS's instructions as well as expected uses.
Cortrak 2 eternal access system The new guidelines direct users to verify that the tube has been placed according to the protocols of the institution before to its use.
Avanos Medical's headquarters are located in Alpharetta Georgia the United States of America. They specialize in manufacturing medical devices. The company's recognized brands are available in over 90 countries.
The company signed an agreement to purchase OrthogenRx for $160 million in December. Avanos Medical concluded the acquisition on the 20th of January.
https://www.openlearning.com/u/jessenhayden-ro5kzx/blog/FdaSMostDangerousRecallsOf2022UnplacedFeedingTubesInspiringAvanosMedical
Website: https://penzu.com/p/36cc0e2f
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