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Avanos Medical is recalling Cortrak*2 Entry Access System. The FDA states that patients have been injured and killed due to nasogastric or the nasoenteric tube being misplaced. The recall covers 629 devices sold in the United States.
Avanos has launched the Cortrak*2 Entraal Access System to help with the placement of a medical feeding tube. Patients may suffer injuries to their vocal cords, lungs, or the trachea, if a tube is not correctly placed. Avanos Medical has reported that there have been more than more than 23 deaths and 60 injuries due to incorrect placement of the nasogastric feeding tubes with the CORTRAK*2 Ental Access System. There have been numerous incidents, including respiratory failure, pneumothorax, collapsed lung, perforation (a hole in the lung's wall or bowel), pneumonia and pleural effusion, which is excess fluid between your lungs and the chest cavity.
https://www.transtats.bts.gov/exit.asp?url=https://medicaldevices.icij.org/devices/hkg-cortrak-2-enteral-access-system-eas Avanos Medical described a plan for patients to receive a new labeling in order to confirm proper use of the nasogastric tube and nasoenteric tubes prior to use.
Avanos was the second caution issued by the FDA in 2022 regarding tube feeding through the stomach. feeding tube placement The FDA sent out a message to parents and healthcare providers about strangulation risk in the event that feeding tubes are used by children. Two cases of child strangulation involving feeding tubes wrapped around the necks of patients have been reported by 2021.
FDA Recalls Avanos Medical Device
Ental Feeding Delivery Sets
Cortrak* 2 Enteral Access System Product Details
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