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Avanos Medical faces Class I recall for feeding tube system linked to 23 deaths in the last year.

After seven years of bad experience with Avanos Medical's feeding tube placement system for children, the FDA has issued its most serious warning regarding the recall of this device.

Cortrak*2 Enteral Access System features an electromagnetic stylet, which includes an external receiver and an LCD monitor. In combination this system lets you see the live placing of a medical feeding tube inside a patient's stomach.

Despite this task, however, the system has been implicated in the occurrence of dozens of patient injuries which led Avanos to announce a recall in January of all Cortrak*2 devices between January 2021 to January 2022. Avanos Medical feeding tube This totals more than 630 devices that were released between April 2016 and the beginning of this year.

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The safety incident does not constitute an recall. https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ Avanos has asked healthcare providers to not send the devices back to the expense of the manufacturer. However, they want to make sure that they are making use of the devices.

A feeding tube that is not properly placed could cause injury to the vocal cords, lungs or trachea. This could lead to serious injuries, or death. Avanos recorded 60 injuries and 23 deaths in 2015, the FDA said. All of these incidents were directly related to FDA's Cortrak*2 system used to place the feeding tube.

Avanos Mediacal Cortrak 2 These injuries can include respiratory failure, collapsed lungs lung infections, pleural effusion and holes in the lungs' walls as well as the esophagus and bowel.

According to FDA, Georgia-based company reminded users in the March 21 Field Correction Notification to "confirm the placement of nasogastric and Nasoenteric tubes as per institution policies". Avanos advised users to include the safety notice in the operation manual of the system and then confirm with Avanos that the update was accepted.

Avanos has indicated that it will soon issue a new label for the device. Cortrak 2 eternal access system The labeling will be able to include the direction to map the tube's location, in accordance with their facility policies.

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This is the FDA's second warning regarding enteral-feeding tubes. In February the FDA issued an safety warning to parents and healthcare professionals regarding the risk of strangulation to children who use feeding tubes.

The announcement came in the wake of two reports of death in 2021. Avanos Mediacal Cortrak 2 The notice came in the wake of two reports of death in 2021. In each case the tubing system was found to have been tied around necks of patients who were under the age of 2.

"While the FDA believes strangulation by tubing for the feeding tube in children is unlikely to result in injuries or death Healthcare providers and caregivers should be aware of this possibility," the FDA stated in the announcement. It also noted that other similar cases might not have been reported to the FDA.


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