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This problem has been the cause for the deaths of 60 and 23 injuries.
This is an item classified as a Class I recall by FDA which is the most severe type. Cortrak 2 eternal access system https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 These devices could lead to serious injuries or even death.
https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ Sam Brusco Associates Editor05.16.22
The FDA has discovered Avanos Medical's recall of their Cortrak*2 intramuscular access device. Since March 21st in 2016, 629 of the devices were recalls in the U.S.
Cortrak*2 is a tool that permits doctors to place medical feeding tubes inside patients stomachs or small bowels.
This recall was initiated due to reports of injury and even death among patients after the incorrect placement of gastric or nasocentric tubes. The device is used to place these tubes. An incorrectly placed nasogastric/nasoenteric tube can cause serious injury or even death.
https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause According to Avanos safety announcement the problem has led to sixty injuries and 23 deaths. The adverse events identified included respiratory failure, perforation, and pneumonia, in addition to pleural effusion.
Cortrak*2 is using this recall to revise the instructions for its use and intended uses. Users will need to verify the location of tubes in accordance with the protocols of institutions before they can deliver nutrition.
Clinicians were requested to attach the correct notice regarding the issue in the operating book, and return the acknowledgement form along with the notification to Avanos. Avanos is hoping to provide users with an updated labels. https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical This will include confirmation that tube placement was done according to institutional policy.
My Website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
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