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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This has led to more than 23 deaths and 60 injuries.

This recall is classed by FDA as a class I recall. This is the most serious type. These devices can cause serious injuries, 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 Sam Brusco is Associate Editor05.16.22

The FDA has discovered Avanos Medical’s recall of their Cortrak*2 intramuscular access system. Beginning on March 21, 2016, 629 devices were recalls in the U.S.

Cortrak*2 helps clinicians place medical feeding tubes into the stomach or in the small bowel of patients who require nutrition through the tube.

The recall was brought on by injury and death reports of patients suffering from nasocentric/nasogastric tube misplacement. This device is used to assist in placing these tubes. Cortrak 2 eternal access system If the tube is not properly placed, it could cause severe injury or death.

As per Avanos safety communication the issue has resulted in more than 23 deaths and 60 injuries. Avanos Medical The adverse events that were identified included perforation, respiratory failure, pneumonia, as well as pleural effusion.

Avanos Medical Cortrak*2 will make use of the recall process to modify its instructions for usage and intended usage. https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 It will advise users to check the placement of tubes by using protocols established by institutions prior to delivering food.

Clinicians were urged to attach the corrective notice for field use regarding the issue to their operating manual and return the acknowledgement form that was enclosed with the notification to Avanos. Avanos Medical Users will soon receive updated labeling and confirmation that the tubes were placed according to institution policy.


My Website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
     
 
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