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There have been 60 injuries and 23 deaths related to this problem.
Cortrak 2 eternal access system This recall has been classed by FDA as a class I recall. This is the most serious form of recall. The devices could cause serious injuries, or even death.
Sam Brusco Associates Editor05.16.22
The FDA has identified the recall by Avanos Medical of their Cortrak*2 enteral access system. feeding tube placement Avanos Mediacal Cortrak 2 The recall of 629 devices that were distributed between 2016 and 2022 started on the 21st of March.
feeding tube placement Cortrak*2 helps clinicians place medical feed tubes on patients who require nutrition through the tube.
This recall was prompted due to reports of injury and deaths in patients due to mistakes in the placement of gastric or nasocentric tubes. The device is used to position these tubes. Nasogastric, also known as the nasoenteric tube, which is not properly placed could cause injury to the vocal cords or the trachea. This can lead to serious injury, or even death.
Avanos Medical According to Avanos, there have been a total of 60 injuries and 23 deaths in connection with this issue. Cortrak 2 eternal access system Pneumothorax and pneumothorax (perforation) and pneumonia and pleural effusion have all been reported as adverse events.
Cortrak*2 will use the recall process to modify its instructions for usage and intended use. It will also instruct users to ensure the tube is placed using institutional protocols before delivering nutritional supplements.
Clinicians were directed to attach the pertinent field correction notice to the operating manual. They must also return the acknowledgement slip included with the Avanos note. Users will soon receive updated labels and confirmation that the tubes were placed according to institution policies.
Avanos Medical feeding tube
Homepage: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement
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