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Avanos Medical faces Class I recall for the feeding tube system that has been linked to 23 deaths since 2015

After seven years in which Avanos Medical's intravenous tube placement device was plagued with unlucky luck, the FDA has given its most severe directive to issue a recall.

Cortrak 2 eternal access system Cortrak 2 eternal access system The Cortrak*2 Enteral Access System includes an electromagnetic stylet with an external receiver as well as a display monitor. Avanos Mediacal Cortrak 2 The system, when combined will provide live footage of the medical tube being placed into a patient's stomach.

Avanos was not satisfied with the mission and launched an recall of all Cortrak*2 units used between January 2021 and January 2022. The recall affected approximately 630 units that were distributed between April 2016 and the beginning this year.

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The safety incident is not a reason to issue the occurrence of a recall. Avanos has asked healthcare providers not to send the devices back to the request of the manufacturer. However, they want to ensure they are correctly making use of the devices.

The incorrect placement of a feeding tube could cause injury to the vocal cords, lungs, or the trachea. Avanos Mediacal Cortrak 2 This can lead to severe injury or death. Avanos has reported 60 injuries and 23 deaths since 2015, FDA declared. https://www.cyberera.com.ng/2022/05/17/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ All of these incidents were related to FDA's Cortrak*2 system that is used to insert the feeding tube.

Avanos Medical feeding tube There are several injuries that have been reported, including respiratory failure, collapsed lung, lung infection.

According to the FDA, the Georgia-based company issued a March 21 field correction note reminding users to verify the location of nasogastric tubes as well as nasoenteric tubs according to institutional policies. Avanos has asked patients to attach a safety notice to their operating manual and to confirm they've updated their manuals.

Avanos Medical Avanos announced that it will shortly issue updated labeling for the device that will include the direction to map out the tube's location in accordance the guidelines of their facility before using the system to help set up the tube.

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This marks the second warning the FDA has issued this year with regard to enteral feeding tubes. Avanos Medical In February, the FDA issued a safety advisory to parents and healthcare providers regarding the danger of strangulation for children who are fed through tubes.

The announcement followed two instances of deaths in 2021. In both instances the tubing system was inadvertently tied around the neck of a child when they weren't being closely monitored by the hospital staff or caregivers.

"The FDA believes that death and serious injuries resulting caused by strangulation with enteral feeding set tubing for children is rare. However, healthcare professionals, and caregivers, should be aware of the possibility that these incidents could and do occur," the FDA said in its notice. The agency suggested that similar incidents may not have yet been reported to the FDA.


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