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Avanos Medical recalls Cortrak*2 EAS after reports of injury and deaths due to tube misplacements.
The US Food and Drug Administration has recognized the Cortrak*2 of Avanos Medical's Enal Access System Recall (EAS) as Class I recall.
The term "Class I Recall" refers to the most severe of the three classes.
Cortrak 2 eternal access system Avanos Medical feeding tube Avanos Medical has recalled Cortrak*2 EAS due to reports of deaths or injuries from nasogastric tube misplacements.
The device is designed to assist health professionals to place medical feeding tubes on patients.
Incorrect placement of Nasogastric tube and nasoenteric tube could cause serious injury or even the death of a patient.
Avanos Medical feeding tube Overall, the company recalls 629 devices distributed across the US between April 1st, 2016 and 1 January 2022.
According to the recall announcement issued by the company the company's recall communication, there were 53 deaths and 60 injuries in 2015 as a result of the misplacement of nasogastric tube feeding tubes during use of the Cortrak* 2 EAS.
Avanos Medical is updating the labels on the device following the recall. Avanos Medical This will include updating the instructions regarding the use and intended usage of Cortrak* 2 EAS.
Users should also confirm that the tubes have been put in the correct manner according to the guidelines of the institution prior to use.
Avanos Medical Avanos Medical, based in Alpharetta Georgia America, is a manufacturer of medical devices that are clinically proven. Cortrak 2 eternal access system The brand's name is available in over 90 countries.
The company entered into a $160m contract in December last year to purchase OrthogenRx. Avanos Medical feeding tube Avanos Medical https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its Avanos Medical closed on the acquisition in January.
Website: https://avanos.com/investor-news/response-to-inquiries-about-the-avanos-cortrak-2-voluntary-field-correction/
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