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FDA has identified Avanos Medical’s Cortrak*2 EAS recall as Class I

Avanos Medical recalled Cortrak* 2 EAS after reports of injuries and patient deaths caused by tube malfunctions.

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

A Class I recall refers to the most severe of the three classes.

feeding tube placement Avanos Medical recalled Cortrak* 2 EAS in the wake of incidents of injury and deaths due to nasoenteric Nasogastric tube misplacements.

The device is intended to assist health professionals place medical feeding tubes onto patients.

However, the wrong placement of the nasogastric or nasoenteric tube could result in severe injuries or even death.

feeding tube placement The company has now removed 629 devices from the US that were distributed between April 1st, 2016 and 1 January 2022.

feeding tube placement The company also stated in a recall notice that there have been more than 23 patients and 60 injuries killed since 2015 because of the misplacement nasogastric feed tubes when using the Cortrak* 2 EAS.

Avanos Medical is updating the marking on the device following the recall. Avanos Mediacal Cortrak 2 This includes updating the directions for use , as well as intended uses of Cortrak*2 EAS.

Avanos Mediacal Cortrak 2 These revised guidelines direct users to ensure that the tube is placed according to the institution's protocols prior use.

Avanos Medical, based in Alpharetta Georgia in the United States is a maker of clinical medical devices. The company has more than 90 markets that are branded with its brands.

The company agreed to buy OrthogenRx for $160 million in December. feeding tube placement Avanos Medical concluded the acquisition on the 20th of January.

Avanos Medical
Website: https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/
     
 
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