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Avanos Medical called off Cortrak* 2 EAS as a result of patient death and injuries caused by tube malfunctions.
Avanos Medical feeding tube The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak* 2 Enteral Access System (EAS) as Class I recall.
A Class I can remember is considered to be the most serious of all three classes.
Avanos Medical Avanos Medical recalled Cortrak* 2 EAS following incidents of injury and deaths caused by nasoenteric and nasogastric tube misplacements.
The device was designed to help medical professionals who are trained to place medical tube feedings within patients, and provide live information about the tube's location in real-time. placement.
Avanos Medical Incorrect placement of Nasogastric tube and nasoenteric tube could cause serious injury or even death.
The company has recall 629 devices, which were made available in the US from April 1st, 2016 until 1 January 2022.
The communication regarding the recall from the company added that there had been sixty injuries and 23 patient deaths since 2015 due to the misplacement or misplacement nasogastric feeding tubes while using the Cortrak* 2 EAS.
After the recall Avanos Medical will update the device's labelling. Avanos Mediacal Cortrak 2 This includes updating the instructions and intended applications for Cortrak* 2 EAS.
The updated guidelines instruct users to verify that the tube has been placed according to the protocols of the institution before to use.
Avanos Medical, based in Alpharetta Georgia America, is a manufacturer of clinical medical devices. The company sells its brands in more than 90 different countries.
The company reached an agreement with OrthogenRx to purchase the company in a $160 million transaction. feeding tube placement Avanos Medical closed on the acquisition in January.
Read More: https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns
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