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Avanos Medical pulled Cortrak*2 EAS off service following reports of injuries and deaths caused by tube missing.
The US Food and Drug Administration has identified Avanos Medical’s Cortrak*2 enteral access system (EAS) to be recalled as a Class II recall.
A Class I recall is the most serious type of the three classes.
Avanos Medical pulled Cortrak* 2 EAS from service after death and injuries of patients due to nasogastric tubes misplacements.
Avanos Mediacal Cortrak 2 The device allows skilled healthcare professionals to insert medical feeding tubes in patients.
However, incorrectly placed nasogastric/nasoenteric pipes could cause harm to the vocal cords and trachea. This can lead to grave injuries or even death.
The company recalls 629 devices sold in the US between January 2016 to January 2022.
Avanos Medical feeding tube According to the company's recall notice the company's recall communication, there were 53 deaths and 60 injuries in 2015 as a result of the incorrect placement of nasogastric feeding tubes in the course of using the Cortrak* 2 EAS.
Avanos Medical, following the recall, will revise the device's labelling. This includes updating the instructions for use and intended uses of Cortrak* 2 EAS.
Avanos Mediacal Cortrak 2 The revised guidelines require users to verify the location of tubes in accordance with protocols from their respective institutions before making use of the tubes.
Avanos Medical, based in Alpharetta Georgia, USA is a producer of medical devices for clinical use. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Avanos Medical's well-known brands are available in over 90 countries.
The company entered into a $160m agreement in December of last year to acquire OrthogenRx. Avanos Medical successfully closed the acquisition of OrthogenRx on the 20th of January.
Here's my website: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement
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