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This issue has been responsible for the deaths of 60 people and 23 injuries.
This is a Class I recall by FDA which is the most serious kind. Avanos Medical These devices could cause serious injuries, and even death.
Sam Brusco, Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall of their Cortrak*2 intramuscular accessibility system. The recall of 629 devices distributed between 2016 and 2022 started on March 21.
Cortrak*2 assists clinicians in placing medical feed tubes into patients who require nutrition through the tube.
The device was removed because of injuries and death reports following nasocentric or nasogastric tube misplacement when the device is used to help place these tubes. feeding tube placement When you are not careful, inserting a nasogastric tube or nasoenteric can result in grave injury or even death.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause According to Avanosthe safety announcement there were 60 deaths and 23 injuries resulting from the issue. Adverse events reported included pneumothorax, respiratory failure perforation, pneumonia, and the pleural effusion.
https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical Cortrak*2 is using this recall to revise the guidelines for usage and intended use. Users must confirm the placement of tubes in accordance with institutional protocols, before they can be used to provide nutrition.
Clinicians were requested to attach the correct notice regarding the issue in the operating book, and return acknowledgment forms along with the notice to Avanos. The company is expected to be able provide the latest labeling to users, including confirmation of the tube's placement as per institutional policies.
Here's my website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
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