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Avanos Medical recalled Cortrak* 2 EAS in the wake of incidents of injury and deaths due to tube misplacements.
The US Food and Drug Administration (FDA) has identified the recall by Avanos Medical of Cortrak*2 Ental Access System, (EAS) as an I class recall.
Avanos Medical Avanos Medical A Class I recall is the most serious kind of the three classes.
feeding tube placement Avanos Medical called off Cortrak* 2, EAS, due to deaths and injuries resulting from the misplacement of tubs for nasogastric surgery.
The device is designed to aid trained health care personnel place medical tube feedings inside patients. It also provides the most current information about tube placement.
But, incorrect positioning of nasogastric/nasoenteric tubes can cause severe injuries, or even death.
The company is recalling 629 devicesthat were made available in the US from 1 April 2016 to 1 January 2022.
The company also noted in a recall announcement that there have been sixty injuries and 23 people that died in 2015 as a result of the incorrect placement of nasogastric feed tubes that were connected to the Cortrak* 2 EAS.
In the wake of the recall Avanos Medical will update the device's labelling. This includes an update of the instructions and the planned uses for Cortrak* 2 EAS.
The revised guidelines also require users to confirm tube placement in accordance with the institution's guidelines prior to using.
Avanos Medical, based in Alpharetta Georgia America is a maker of medical devices that are clinically proven. https://www.metooo.io/u/636d1619b0716d7b0476da52 Avanos Mediacal Cortrak 2 https://www.fcc.gov/fcc-bin/bye?https://martinmahler1.livejournal.com/profile The company's products are distributed in more than 90 countries.
The company agreed to buy OrthogenRx for $160 million in December. Avanos Medical feeding tube Avanos Medical successfully closed the acquisition of OrthogenRx in January.
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