Avanos Medical faces a Class I recall for its the feeding tube system that was linked to 23 deaths in 2015.
The FDA has given its most severe warning in relation to the recall of Avanos Medical’s feed tube enteral positioning system.
Cortrak*2 Enteral Access System has an electromagnetic stylet and an external receiver. It also has an LCD monitor. In combination, the system allows you to view the actual placing of a medical feeding tube into a patient's stomach.
Avanos issued an earlier this month a recall of every Cortrak*2 device that was used between January 20,21 until January 20,22. The recall affected nearly 630 devices.
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The safety incident is not a recall in its literal sense: Avanos does not ask medical professionals to return devices to the manufacturer. Instead, it wants to ensure they're using the devices properly.
Incorrectly inserting a feeding tube could cause injury to the vocal cords, lungs or the trachea. This can lead to severe injury or death. feeding tube placement In actual fact, Avanos has received reports of deaths of 23 and 60 injuries since 2015, the FDA said that all of them were related to the use of the Cortrak*2 system to guide the placement of a feeding tube.
Some of the injuries reported include respiratory failure and lung collapse, lung infections, and holes in the walls the esophagus and the lungs.
According to FDA Avanos, a Georgia-based business issued a field correction notice reminding patients to confirm the position of nasogastric and tubs for the nasoenteric system according to institution policies. Avanos has also asked users to add the safety notice to the operating manual of the device and verify that they've received the latest update.
feeding tube placement Avanos indicated that it will soon issue updated labels for the device. These will include the direction of how to place a tube, in accordance with the company's policies.
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This marks the second warning that the FDA has issued in the past year in regards to feeding tubes for the enteral system. In February, the FDA published the safety announcement informing parents as well as healthcare professionals of the possibility of strangulation due to the use of feeding tubes by children.
The announcement came in the wake of two reports of death in 2021. The notice followed two reports of death in 2021. In each case, the tubing system was found to be placed around necks of patients younger than age 2.
"The FDA believes that death and serious injuries resulting caused by strangulation with tubing used for enteral feeding for children is rare. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause But, healthcare professionals and their caregivers should be aware that these events can and do happen," the FDA said in the announcement. The agency suggested that similar cases could not yet be reported to FDA.