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This issue has caused more than 23 deaths and 60 injuries.
The FDA has classified this as an Class I recall, the most severe type of recall. Use of these devices may cause serious injury or death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system for enteral access. 629 devices that were distributed between 2016 and 2022 were recalled within the U.S., beginning on March 21.
Avanos Medical Cortrak*2 aids clinicians to place medical feeding tubes into the stomach or in the small bowel of patients needing to receive nutrition via the tube.
Cortrak 2 eternal access system https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges Avanos Medical The system was recalled due to injury and patient deaths resulting from nasocentric or Nasogastric tube misplacement, when the device is used to put these tubes in the right place. Avanos Medical Improperly inserting a tube for nasogastric or nasoenteric tube can result in grave injury and even cause death.
https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ According to Avanos’ safety communication, there were 60 deaths and 23 injuries that were related to the issue. Avanos Medical Pneumothorax, pneumothorax (perforation) and pneumonia and pleural effusion were all reported as adverse events.
This recall is used to revise Cortrak*2's instructions for use, intended uses, and remind users to confirm tube placement in accordance with institutional guidelines prior to making use of the tube to provide nutritional benefits.
Clinicians were also advised to attach the amended field notice on the issue to Avanos' operating manual, and return the acknowledgement forms that came in Avanos' notice. https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf The users will shortly receive an update to the labeling and confirmation that the tubes were placed according to institution policies.
Here's my website: https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/
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