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Avanos Medical recalls Cortrak*2 EAS following reports of injuries and deaths due to tube malfunctions.
The US Food and Drug Administration has recognized Avanos Medical's Cortrak*2 Enal Access System Recall (EAS) as a Class I recall.
A Class I recall is the most serious kind of the three classes.
Avanos Medical called off Cortrak* 2, EAS, after deaths and injuries that resulted from the misplacement of tubs for nasogastric surgery.
The device is designed to aid health care professionals to place medical feeding tubes onto patients.
https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical However, the wrong positioning of nasogastric or nasal tubes could cause damage to the vocal cords of a patient, lungs or trachea which can cause serious injury or even death.
The company recalls 629 devices sold in the US between January 2016 and January 2022.
The company also stated in a recall announcement that there were 60 injuries and 23 patients killed since 2015 because of the misplacement nasogastric feed tubes when using the Cortrak* 2 EAS.
In the wake of the recall Avanos Medical will update the device's labelling. feeding tube placement https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause This includes an update of the instructions and the planned uses for Cortrak* 2 EAS.
The updated guidelines instruct users to check the placement of tubes according to the institution's protocols prior to use.
Avanos Medical is based in Alpharetta (Georgia) in the United States. feeding tube placement Its focus is on the manufacturing of medical devices. Avanos Medical The company has more than 90 markets to sell its renowned brands.
https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement In December of last year, the company reached an agreement to purchase OrthogenRx with a $160m deal. Avanos Medical closed the acquisition on 20 January.
Read More: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
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