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Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries and deaths from tube malfunctions.
Avanos Medical feeding tube The US Food and Drug Administration has confirmed Avanos Medical's Cortrak*2 enal Access System Recall (EAS) as Class I recall.
A Class I recall is the most serious kind out of the three classes.
Avanos Medical called off Cortrak* 2, EAS, after deaths and injuries that resulted from the misplacement of nasogastric tubs.
Avanos Medical The device is able to aid trained health professionals with the placement of medical feeding tubes in patients. https://www.transtats.bts.gov/exit.asp?url=https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical It also gives real-time information about tube placement.
However, the wrong placement of the nasogastric, or nasoenteric tube could cause serious injury or even death.
The company is recalling 629 devices, 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 were more than 23 patients and 60 injuries killed since 2015 because of the misplacement nasogastric feed tubes that were connected to the Cortrak* 2 EAS.
Avanos Medical, following the recall, will be updating the labeling of the device. This will include an update of the instructions for use and intended uses of Cortrak* 2 EAS.
Cortrak 2 eternal access system The updated guidelines require that users confirm the position of tubes according to protocols issued by their institutions before using them.
Avanos Medical, based in Alpharetta Georgia, USA is a producer of medical devices for clinical use. Avanos Medical's well-known brands are available in more than 90 countries.
The company agreed to acquire OrthogenRx at $160 million during December. feeding tube placement Avanos Medical completed the acquisition on January 20.
Avanos Medical feeding tube
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