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There are 60 reported injuries and 23 deaths related to this issue.
This is a Class I recall issued by FDA which is the most serious kind. https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ Use of these devices may cause serious injuries or death.
Sam Brusco Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of the Cortrak*2 user access system. 629 devices, which were distributed between 2016 - 2022, were recalled by the U.S. starting on March 21.
Avanos Medical Cortrak*2 helps clinicians place medical feeding tubes into the stomach or small bowels of patients who require nutrition via tube.
The device was temporarily recalled due to injury and patient death reports following nasocentric or Nasogastric tube misplacement, when the device is used to help place these tubes. If a nasogastric or nasoenteric tube is incorrectly inserted there could be damage to the vocal cords, lungs or trachea, which can result in serious injury or death.
According to Avanosthe safety announcement there were 60 deaths and 23 injuries resulting from this problem. The adverse events mentioned included perforation, respiratory failure, pneumonia, in addition to pleural effusion.
feeding tube placement The recall is being used to modify Cortrak*2's directions on use and intended use, instructing users to confirm the placement of the tube according to institutional protocols before using the tube to deliver nutrition.
Clinicians were advised to attach the corrective field notice about the issue in their operating manual and to return the acknowledgement form that was enclosed with the notification to Avanos. Avanos Medical Avanos Medical feeding tube The company plans to provide users with current labels, along with confirmation of placement of tubes in accordance with the institutional guidelines.
Avanos Medical feeding tube
Website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
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