Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement

This issue has led to 60 injuries, and 23 deaths. This is an item classified as a Class I recall issued by FDA that is the most serious kind. Utilizing these devices can result in serious injuries or even death. Sam Brusco is Associate Editor05.16.22 The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system of enteral access. 629 devices manufactured between 2016 to 2022 were recalled with the first recall occurring on the 21st of March. Avanos Medical feeding tube Cortrak*2 permits clinicians to insert medical feeding tubes inside the stomach or small bowel of patients that require nutrition. The device was removed because of injury and death reports following nasocentric or nasogastric tube misplacement when the device is used to help put these tubes in the right place. Cortrak 2 eternal access system An incorrectly placed nasogastric/nasoenteric tube can result in severe injuries or even death. Cortrak 2 eternal access system According to AvanosSafety Communication there were 60 deaths and 23 injuries related to this problem. Pneumothorax (perforation), pneumothorax (perforation), pneumonia, and pleural effusion were all reported as adverse events. Avanos Medical https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Cortrak*2 is using the recall to make updates to its guidelines for use. The updated guidelines will contain instructions for users to verify that tubes are placed according to the guidelines of the institution before applying them to provide nutrition. Clinicians were also advised to include the field correction notice to the operating manual and return the acknowledgement form included with the notification to Avanos. Avanos plans to offer users new labeling and confirmation of the placement of tubes as per the policies of the institution prior to the use.

FDA has identified Avanos Medical's Cortrak* 2 EAS recall as Class I

Avanos Medical recalls Cortrak*2 EAS after reports of injury and death due to tube misplacements. The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak* 2 Enteral Access System (EAS) as an I Class recall. The most severe of the three kinds is the Class I recall. Avanos Medical recalls Cortrak*2 EAS after reports of injuries and death due to misplacements of nasogastric or nasoenteric tubes. The device is designed to assist health professionals to place medical feeding tubes on patients. https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns But, incorrect placement of nasogastric/nasoenteric tubs can cause severe injuries, or even death. In total, the company has recalled 629 devices that were sold across the US between April 1st, 2016 to 1 January 2022. The recall communication from the company also stated that there had been more than 23 patient deaths since 2015 due to the misplacement of the nasogastric feeding tubes when using the Cortrak* 2 EAS. Cortrak 2 eternal access system Avanos Medical is updating the marking on the device following the recall. This will include updating the instructions for use and intended usages of the Cortrak*2 EAS. The updated guidelines instruct users to ensure that the tube has been placed according to the protocols of the institution before usage. Avanos Medical's headquarters are located in Alpharetta Georgia USA. Cortrak 2 eternal access system They are a specialist in the production of medical equipment. Avanos Medical feeding tube The brand's name is sold in over 90 countries. Avanos Medical In December of last year, the company entered into an agreement worth $160 million to purchase OrthogenRx. Avanos Medical successfully closed the acquisition of OrthogenRx on the 20th of January. Avanos Medical feeding tube Avanos Medical feeding tube