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The issue has caused at the very least 60 injuries and 23 fatalities.
This recall is classified by FDA as a class I recall. This is the most serious form of recall. These devices can cause serious injuries or even death.
Avanos Medical feeding tube Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of Cortrak*2 enteral access system. 629 devices manufactured between 2016 until 2022 were recalls, with the first recall happening on March 21.
Cortrak*2 assists clinicians in placing medical feeding tubes into the stomach or in the small bowel of patients needing to receive nutrition via the tube.
The recall was initiated in response to reports of injuries and death in patients following the incorrect placement of gastric or nasocentric tubes. https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html The device is used to position these tubes. If a nasogastric tube is not correctly inserted, damage can occur to the vocal cords, lungs or the trachea, leading to serious injury or death.
Avanos Medical feeding tube According to Avanos' safety communications the number of injuries was 60 and 23 fatalities related to this incident. There were several adverse events that occurred, including pneumothorax, respiratory failure, perforation, pneumonia and pleural effusion.
https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas https://www.hcplive.com/view/fda-issues-letter-to-health-care-providers-about-pneumothorax-events Cortrak*2 will use this recall to revise the instructions for its use and intended uses. Users must confirm the placement of tubes based on the protocols of institutions before they are able to deliver nutritional supplements.
Clinicians were urged to attach the corrective field notice about the issue in their operating manual and return the acknowledgement form which was enclosed with the notification to Avanos. Avanos will shortly be able to provide updated labeling for users, which will include confirmation of the tube's placement in accordance with the institutional guidelines.
Read More: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
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