Avanos Medical faces Class I recall for the feeding tube system linked to 23 deaths in the last year
After seven years in which Avanos Medical's tube placement system was plagued with unlucky luck, the FDA has given its most severe instructions to issue a recall.
Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also includes an LCD monitor. When used together it provides a live feed of the positioning of a medical feeding tube into the stomach of a patient or into their small bowel, with an goal of improving the precision of the tube's tip positioning and reducing the risk of complications.
Despite that goal, however, the system has been implicated in many injuries sustained by patients, leading Avanos to launch a recall earlier this year of all Cortrak*2 devices used between January 2021 to January 2022. https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ This totals around 630 devices initially distributed between April 2016 until the beginning of this year.
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The safety event is not considered to be a recall. Cortrak 2 eternal access system Avanos has asked healthcare providers to not send the devices back to the request of the manufacturer. Cortrak 2 eternal access system But, they would like to ensure they are correctly using the devices.
Incorrectly inserting the feeding tube can result in harm to vocal cords and the lungs. Avanos Mediacal Cortrak 2 According to the FDA, Avanos received reports of 23 deaths and 60 injuries since 2015, all related to the FDA's use of the Cortrak*2 system to guide the installation of a feeding tube.
There are a variety of injuries that have been reported, like respiratory failure, collapsed lung, and lung infection.
Avanos Medical feeding tube According to the FDA, the Georgia-based company issued a March 21 field correction notice reminding patients to confirm the placement of nasogastric tubes and nasoenteric tubs according to institutional guidelines. Avanos is requesting that users include a safety note in their operating manuals and verify they have been updated.
Cortrak 2 eternal access system Avanos announced that they will soon issue an updated labeling for the device. It will include the instructions for placing a tube according to their guidelines.
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The FDA has issued a second warning regarding feeding tubes for enteral nutrition. In February, the FDA published a safety announcement informing parents and health professionals of the possibility of strangulation as a result of the use of feeding tubes for children.
Two deaths in 2021 were not reported to the notice. The notice came in the wake of two deaths in 2021. In each case, the tubing system was found to be wrapped around the necks of patients under the age of 2.
"The FDA believes that strangulation via enteral feed set tubing children is uncommon, but healthcare professionals and caregivers have be aware that these events can and do happen," the agency stated in the notice. This suggests that similar cases could not have been reported to the FDA.
Cortrak 2 eternal access system
