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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This problem has caused 60 injuries and 23 deaths.

This is an item classified as a Class I recall issued by FDA that is the most severe type. The devices could result in 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 device. 629 devices, distributed between 2016 and 2022 were recalled by the U.S. starting on March 21.

Cortrak*2 helps clinicians place medical feeding tubes inside the stomach or small bowels of patients who require nutrition via tube.

Avanos Medical https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding feeding tube placement The recall was brought on by reports of death and injuries of patients suffering from nasocentric/nasogastric tube mistaken placement. Avanos Medical feeding tube This device is used for helping to place these tubes. An incorrectly placed nasogastric/nasoenteric tube can result in severe injury or death.

According to Avanos Safety Communication There have been 53 deaths and 60 injuries in connection with this incident. The adverse events that were identified included perforation, respiratory failure and pneumonia, as well as the development of pleural effusion.

Cortrak*2 has utilized the recall to make updates to its instructions for use. The new instructions provide users with a way to verify that tubes are placed in accordance with institution protocols before making use of them to deliver food.

Avanos Medical Clinicians were also advised to add the updated field notice on the issue to Avanos' operating manual, and return the acknowledgement forms that came with Avanos' notice. Avanos plans to offer users the most current labeling, as well as confirmation of placement of tubes in accordance to institutional policies.


Website: https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/