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This issue has been responsible for the deaths of 60 people and 23 injuries.
This is a Class I recall issued by FDA which is the most serious kind. The devices could result in serious injuries and even death.
Cortrak 2 eternal access system Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 useal access system. 629 devices, distributed from 2016 and 2022 were recalled by the U.S. starting on March 21.
Cortrak*2 assists clinicians in placing medical feeding tubes in the stomach or small bowels of patients who require nutrition via tube.
This recall was prompted because of reports of injuries and even death among patients after the incorrect placement of gastric or nasocentric tubes. https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas The device is used to position the tubes. Avanos Medical If a nasogastric or nasoenteric tube is not correctly inserted, damage can occur to the vocal cords, lungs, or trachea, which can result in grave injury or even death.
According to Avanos Safety communications there were 60 injuries and 23 fatalities related to this issue. The adverse events that were reported include pneumothorax, respiratory failure perforation, pneumonia, as well as pleural effusion.
Cortrak 2 eternal access system Cortrak*2 is using this recall to revise the guidelines for usage and intended use. Users will need to verify the location of tubes in accordance with institutional protocols, before they are able to deliver nutritional supplements.
Avanos Mediacal Cortrak 2 Clinicians were also advised to attach the field correction notice about the issue to the operating manual , and return the acknowledgement form that was included in the notice to Avanos. The company is planning to provide users with current labels, as well as confirmation of placement of tubes in accordance to institutional policies.
Read More: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery
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