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The issue has caused at the very least 60 injuries and 23 fatalities.
Avanos Medical Cortrak 2 eternal access system The FDA has identified this as an Class I recall, which is the most serious kind of recall. These devices could lead to severe injuries or even death.
feeding tube placement Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical as the company responsible for recalling its Cortrak*2 system of enteral access. 629 devices, distributed between 2016 - 2022, were recalls by the U.S. starting on March 21.
Cortrak*2 is a tool that allows doctors to insert medical feeding tubes in patients stomachs, or small bowels.
The recall of the system was caused by patient deaths and injury following misplacement of nasocentric/nasogastric tubes. These tubes assist in the placement of them. https://independent.academia.edu/MckeeBlackburn If a nasogastric, or nasoenteric tube is inserted incorrectly, damage can occur to the vocal cords, lungs or trachea, which can result in serious injury or death.
According to AvanosSafety Communication, there were 60 deaths and 23 injuries resulting from this issue. Avanos Medical feeding tube Pneumothorax and pneumothorax (perforation) pneumonia, and pleural effusion have all been listed as adverse events.
Cortrak*2 is using this recall to update its instructions for the use and intended usage. Users will need to verify the location of the tubes according to institutional protocols, before they can be used to provide nutrition.
Clinicians were also advised to add the updated note in the field on the issue to Avanos' operating manual, and to return the acknowledgement forms that came with Avanos' notice. Avanos plans to offer users the most current labeling, and also a confirmation of placement of tubes in accordance to institutional policies.
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