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This problem has caused 60 injuries, and 23 deaths.
Avanos Medical feeding tube This recall has been identified by the FDA as an Class I recall. It is the most serious type of recall. Cortrak 2 eternal access system The devices could result in grave injuries, and possibly death.
Avanos Medical feeding tube Sam Brusco, Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall for its Cortrak*2 oral access device. 629 devices, which were distributed between 2016 and 2022, were recalled by U.S. starting on March 21.
Cortrak*2 helps clinicians place medical feeding tubes in the stomachs or small bowels of patients who need to be fed via the tube.
Due to injuries and deaths, the system was recalled. Avanos Medical Nasogastric, also known as the nasoenteric tube, that isn't properly inserted could result in damage to the vocal chords and trachea. This could lead to serious injury, or even death.
According to AvanosSafety Communication there were 60 deaths and 23 injuries resulting from the issue. The adverse events that were mentioned included perforation, respiratory failure and pneumonia, as well as the pleural effusion.
Cortrak*2 has used this recall to update its instructions for usage and intended use. Users will need to confirm the placement of the tubes according to the protocols of institutions before they are able to deliver nutritional supplements.
Clinicians were instructed to add the appropriate field correction notice to their operating manual. Cortrak 2 eternal access system Avanos Medical They must also return the acknowledgement form that came with the Avanos notification. Avanos will shortly be able to send out updated labeling for users, which will include confirmation of the placement of tubes according to the policies of the institution.
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