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Avanos Medical and the FDA have issued a Class 1 recall of 629 units of CORTRAK*2 Entral Access System, a feeding tube placement device associated with dozens of accidents and deaths.
These devices were distributed between April 1, 2016 and January 1, 2022. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery These devices are utilized by healthcare professionals to insert feeding tubes into stomachs of patients or intestines.
Cortrak 2 eternal access system Since 2015, there have been 20 deaths and 60 injuries reported for nasogastric or nasal tubes that were improperly placed.
The recall is used to modify the label of the device to instruct users to verify that the tube has been correctly placed before delivering nutrition.
Avanos Medical feeding tube "Adverse events reported included respiratory failure and pneumothorax (collapsed lung), perforation (a hole in the wall of the lung or esophagus or bowel) as well as pneumonia (a lung infection) and pleural effusion (excess fluid in the lung space and the chest cavity)," according to the FDA.
Avanos Medical 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 Mediacal Cortrak 2
Homepage: https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges
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