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Avanos Medical recalls Cortrak*2 EAS in the wake of reports of injury and even death caused by tube malfunctions.
The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak*2 Enteral Access System (EAS) as a Class I recall.
A Class I remember is considered to be to be the most important of the three classes.
Avanos Mediacal Cortrak 2 Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths due to misplacements of the nasogastric tube.
The device is designed to help health care workers to place medical feeding tubes onto patients.
But, incorrect placement of nasogastric/nasoenteric tubs can result in severe injuries or even death.
Avanos Medical feeding tube The company recalls 629 devices sold throughout the US between January 2016 to January 2022.
The company recall communication stated that 60 patients were injured and 23 died due to misplacement in nasogastric tubes while using Cortrak* 2 EAS.
Avanos Medical is updating the labels on the device following the recall. This will include an update of the instructions and the planned uses for Cortrak* 2 EAS.
Users are also directed to confirm that the tubes have been placed according to protocols of the institution prior to utilize them.
Avanos Medical has its headquarters in Alpharetta Georgia. feeding tube placement The company markets its recognised brands in over 90 countries.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause The company agreed to acquire OrthogenRx for $160 million in December. Avanos Medical successfully closed the acquisition of OrthogenRx on the 20th of January.
Homepage: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
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