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Avanos Medical and FDA issued a Class 1 recall of 629 CORTRAK*2 Enteral Access System, which is a feeding tube placement device linked to many incidents of injury and death.
Avanos Medical feeding tube Cortrak 2 eternal access system The recall devices were made available from April 1, 2016 to January 1, 2022. https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ These devices can be used by health professionals to insert feeding tubes in the stomach or intestines.
Since 2015, there have been 20 deaths and 60 injuries reported for nasogastric or nasal tubes that were improperly placed.
https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 This recall will be used to correct the label on the device so that it reminds users to check that the tube was correctly placed before they can deliver the food.
According to FDA the adverse events include respiratory failure and pneumothorax (collapsed lungs), perforation [a hole in the bowel or wall of the lung], pneumonia (a lung infection) and the pleural effusion (excess fluid in the lung space and the chest cavity).
For more information, customers with questions or concerns about this recall should contact Avanos Medical by phone at 470-448-5444 or by emailing [email protected]. Avanos Medical
Here's my website: https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/
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