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Avanos Medical called off Cortrak* 2 EAS as a result of patient deaths and injuries caused by tube malfunctions.
The US Food and Drug Administration (FDA), has identified the recall issued by Avanos Medical of Cortrak*2 Ental Access System, (EAS) as an class I recall.
A Class I recall is considered the most serious of all three classes.
Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths due to misplacements of the nasogastric tube.
The device was designed to assist healthcare professionals with training to insert medical tube feedings inside patients. It also provides the most current information about tube placement.
However, the wrong placement of nasogastric and nasoenteric tubes can damage a patient's vocal cords, lungs or trachea, resulting in serious injury or even death.
Avanos Mediacal Cortrak 2 https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ The company has recall 629 units, which were made available across the US from April 1st, 2016 to 1 January 2022.
Avanos Mediacal Cortrak 2 In the recall announcement, the company stated that as of 2015, there had been 60 injuries as well as 23 deaths due to the misplacement or use of Nasogastric feeding tubes while using the Cortrak* 2 EAS.
feeding tube placement Avanos Medical will revise the labelling after the recall. This includes updating Cortrak*2 EAS's instructions and the intended use.
The updated guidelines instruct users to verify that the tube has been placed according to the protocols of the institution before to use.
Avanos Mediacal Cortrak 2 Avanos Medical feeding tube Avanos Medical Avanos Medical, based in Alpharetta Georgia in the United States is a producer of clinical medical devices. Its brands are sold in over 90 countries.
The company agreed to buy OrthogenRx at $160 million during December. Avanos Medical successfully closed the acquisition of OrthogenRx on the 20th of January.
Homepage: https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns
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