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Avanos Medical recalls Cortrak*2 EAS following reports of injuries and deaths due to tube malfunctions.
Avanos Mediacal Cortrak 2 The US Food and Drug Administration has identified the Cortrak*2 of Avanos Medical's enteral access system (EAS), for recall as an Class II recall.
The most serious of the three types is the Class I remember.
Avanos Medical recalled Cortrak* 2 EAS following reports of injuries and deaths caused by nasoenteric and nasogastric tube misplacements.
The device allows skilled healthcare personnel to place medical feeding tubes in patients.
Avanos Mediacal Cortrak 2 Avanos Medical feeding tube But, incorrect placement of nasogastric/nasoenteric tubs can result in severe injuries or even death.
The company is recalling 629 units, which were sold in the US from April 1st, 2016 until 1 January 2022.
According to the recall announcement issued by the company the company's recall communication, there were sixty injuries and 23 deaths in 2015 due the incorrect placement of nasogastric feeding tubes during use of the Cortrak* 2 EAS.
Avanos Medical will revise the labelling after the recall. This will include updating the instruction for use as well as the intended use of Cortrak*2 EAS.
Revisioned guidelines require users to verify the placement of tubes in accordance with protocols from their respective institutions prior to using the tubes.
Based in Alpharetta, Georgia, US, Avanos Medical focuses on the production of medical devices that are clinically proven. Its brands are available in more than 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 came to an agreement with OrthogenRx to purchase the company for $160 million in a transaction. Avanos Medical successfully closed the acquisition of OrthogenRx on 20 January.
Here's my website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
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