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This issue has been responsible for the deaths of 60 people and 23 injuries.
https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges This recall has been identified by the FDA as classified as a Class I recall. Cortrak 2 eternal access system It is the most severe type of recall. These devices can cause serious injury or even death.
Sam Brusco is Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall for the Cortrak*2 oral access system. 629 devices manufactured between 2016 to 2022 were recalled in the U.S., beginning on March 21.
https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview Cortrak*2 helps clinicians place medical feeding tubes into the stomach or small bowels of patients who need to be fed through the tube.
The recall of the system was due to patient deaths and injury following the incorrect placement of nasocentric/nasogastric tubes. These tubes are used to aid in placing them. Avanos Medical feeding tube If the tube is not properly placed, it could cause severe injury or death.
According to Avanos the number of incidents has been a total of 60 injuries and 23 deaths in connection with this issue. Some of the adverse events reported were pneumothorax, respiratory failure, perforation, pneumonia and the development of pleural effusion.
Cortrak*2 is using this recall to improve its instructions for usage and intended use. Avanos Medical The users will have to confirm the placement of tubes in accordance with the protocols of institutions before they can deliver nutrition.
Clinicians were also advised to include the field correction notice about the issue to the operating manual and return the acknowledgement form included with the notification to Avanos. Avanos hopes to provide users with an updated labels. This will include confirmation that the placement of the tube was performed in accordance with the institution's policies.
Read More: https://www.raps.org/regulatory-focus™/news-articles/2018/1/fda-warns-doctors-of-collapsed-lungs-and-deaths-possibly-linked-to-feeding-tube-placement-devices
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