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Avanos Medical recalls Cortrak*2 EAS following reports of injuries and even death caused by tube misplacements.
The US Food and Drug Administration has classified Avanos Medical's Cortrak*2 enteral Access System (EAS), as a Class 1 recall.
Cortrak 2 eternal access system A Class I recall is a reference to the most difficult of three classes.
Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and patient deaths due to nasoenteric nasogastric tube misplacements.
The device was designed to help healthcare professionals with training to insert medical tube feedings within patients, and provide real-time location information on tube placement.
The wrong placement of Nasogastric or nasoenteric tubes can result in serious injuries or the death of a patient.
Avanos Medical Overall, the company recalls 629 devices sold in the US between April 1st, 2016 and 1 January 2022.
The recall notification from the company said that 60 patients had been injured and 23 died due to misplacement in nasogastric tubes while making use of Cortrak* 2 EAS.
Cortrak 2 eternal access system Avanos Medical will make the necessary updates to the labelling of the device following the recall. Avanos Medical https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding This includes updating the instructions on how to use the device as and the intended uses for Cortrak*2 EAS.
Revisioned guidelines require users to verify the placement of tubes according to protocols issued by their institutions before making use of them.
Avanos Medical, based in Alpharetta Georgia in the United States is a maker of medical devices for clinical use. The company has more than 90 markets to sell its renowned brands.
The company entered into a $160m agreement in December of last year to acquire OrthogenRx. Avanos Medical successfully closed the acquisition of OrthogenRx on 20 January.
Website: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm
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