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Avanos Medical has recalled Cortrak*2 EAS in response to reports of injuries and deaths due to tube displacements.
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.
Avanos Medical feeding tube The Class 1 recall is the most severe of three classes.
Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and patient deaths due to nasoenteric or Nasogastric tube malfunctions.
The device is able to assist trained health professionals with the placement of medically-approved feeding tubes for patients. It also provides in real-time information about tube placement.
However, the incorrect positioning of the nasogastric or nasoenteric tubes could result in severe injuries or even death.
https://trungtamytehoavang.com.vn/question/avanos-medical-recalls-cortrak2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm-44/ In total, the company has recalled 629 devices that were sold in the US between 1 April 2016 and 1 January 2022.
According to the recall notice the company said that in the year 2015, there have been 60 injuries and 23 deaths due to the misplacement or misuse of the Nasogastric feeding tubes while making use of the Cortrak* 2 EAS.
Avanos Medical, following the recall, will update the device’s labelling. This will include updated instructions on how to use the device and the intended use of the Cortrak*2 EAS.
The revised guidelines advise users to ensure that the tube was set up according to the protocol of the institution before to its use.
Avanos Medical, based in Alpharetta Georgia in the United States, is a manufacturer of medical devices that are clinically proven. Cortrak 2 eternal access system Its brands are available across more than 90 countries.
The company agreed to buy OrthogenRx for $160 million in December. https://www.ted.com/profile Avanos Medical successfully closed the acquisition of OrthogenRx on 20 January.
https://www.transtats.bts.gov/exit.asp?url=https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
Website: https://www.metooo.io/u/62aebf901dcfdc1193458101
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