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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 kind. These devices can lead to serious injuries and even death.

Sam Brusco Associates Editor05.16.22

The FDA has confirmed Avanos Medical’s recall for its Cortrak*2 oral access system. 629 devices made between 2016 and 2022 were recalled, with the first recall occurring on the 21st of March.

Cortrak*2 aids clinicians when placing medical feeding tubes inside the stomachs or small bowels of patients who require to be fed via the tube.

Avanos Medical feeding tube The recall was brought on by injury and death reports from patients after nasocentric/nasogastric tube misplacement. This device is utilized for helping to place the tubes. An incorrectly placed nasogastric/nasoenteric tube can cause serious injury or death.

According to AvanosSafety Communication there were 60 deaths and 23 injuries resulting from this problem. Avanos Mediacal Cortrak 2 Cortrak 2 eternal access system Pneumothorax, pneumothorax (perforation) and pneumonia and pleural effusion have all been identified as adverse events.

This recall is utilized to modify Cortrak*2's guidelines regarding use, intended usage, and remind users to confirm tube placement as per institutional guidelines prior to using the tube in order to deliver nutrition.

https://www.medicalbuyer.co.in/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/ Clinicians were also advised to attach the field correction note to the operating guideline and return the acknowledgement forms included in the notice to Avanos. https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/ Users will soon receive updated labels and confirmation that tubes were placed according to institution policies.


Homepage: https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/