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Avanos Medical has recalled Cortrak*2 EAS in response to reports of injuries and deaths caused by tube displacements.
The US Food and Drug Administration has identified Avanos Medical's Cortrak*2 entry access system (EAS), for recall as an Class II recall.
A Class 1 recall is the most serious of three classes.
Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths from nasogastric tube misplacements.
The device was developed to aid trained health care professionals when placing medical feed tubes in patients.
Avanos Medical A wrong placement of the Nasogastric tube and nasoenteric tube could cause serious injury or even death.
The company recalls 629 devices sold throughout the US between January 2016 and January 2022.
In the recall announcement the company has stated that as of 2015, there had been 60 injuries and 23 deaths as a result of the misplacement or misuse of the nasogastric feeding tube while making use of the Cortrak* 2 EAS.
https://lexsrv3.nlm.nih.gov/fdse/search/search.pl?match=0&realm=all&terms=https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ Avanos Medical, following the recall, will be updating the device's labelling. Avanos Medical feeding tube This includes changing the instructions as well as the intended applications of Cortrak* 2 EAS.
Avanos Medical feeding tube The revised guidelines also direct users to confirm tube placement in accordance with the institution's guidelines prior to using.
Avanos Medical, based in Alpharetta Georgia in the United States, is a manufacturer of medical devices for clinical use. Avanos Mediacal Cortrak 2 The company sells its recognized brands across over 90 countries.
Avanos Mediacal Cortrak 2 The company agreed to buy OrthogenRx for $160 million in December. Avanos Medical successfully closed the acquisition of OrthogenRx on 20 January.
Website: https://lexsrv3.nlm.nih.gov/fdse/search/search.pl?match=0&realm=all&terms=https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
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