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There were 60 injuries as well as 23 deaths related to this issue.
https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ This is an item classified as a Class I recall issued by FDA, which is the most severe type. These devices could lead to grave injuries, or even death.
Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 access device for use in the system. 629 of the devices produced between 2016 to 2022 were recalled with the first recall occurring on March 21.
Cortrak*2 helps clinicians place medical feeding tubes in the stomachs or small bowels of patients who need to be fed by the tube.
Cortrak 2 eternal access system The system was recalled because of injury and deaths resulting from nasocentric or nasogastric tube misplacement when it is employed to help put these tubes in the right place. https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ A nasogastric, or nasal, tube which is not properly placed can cause damage to the vocal chords and the trachea. It could result in serious injuries, or death.
According to Avanos' safety communication, there have been 60 injuries and 23 deaths related to this issue. Avanos Medical feeding tube A variety of adverse events were identified which included respiratory failure, pneumonia and pneumothorax.
This recall will be utilized to modify Cortrak*2's guidelines on use, intended use and also remind users to verify tube placement according to institutional protocols before using the tube in order to supply nutrients.
Clinicians were directed to attach the appropriate field correction notice to their operating manual. They should also return the acknowledgement sheet included along with the Avanos notice. Avanos Medical feeding tube The users will shortly receive an update to the labeling and confirmation that tubes were placed in accordance with institution guidelines.
Website: https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/
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