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Avanos Medical faces Class I recalls for its feeding tube systems connected to 23 deaths in 2015

After seven years of adversity for the enteral feeding tube placement system Avanos Medical's enteral feeding tube placement system, the FDA has issued its most serious designation for a recall of the device.

Cortrak*2 Enteral Access System features an electromagnetic stylet that includes an external receiver, a monitor for display as well as an electronic receiver. It allows you to observe the real-time positioning of a medical feed tube in a patient's stomach.

Avanos announced the recall earlier in the month of all Cortrak*2 device in use between January 20,21 between January 20,22 and January 20,21. Avanos Mediacal Cortrak 2 The recall affected nearly 630 devices.

Cortrak 2 eternal access system The incident that caused the safety issue does not mean that there is the occurrence of a recall. Avanos has asked healthcare providers not to return the devices to their manufacturers. Avanos only wants to make sure that the devices are properly used.

If a tube for feeding is incorrectly installed, it may cause damage to the vocal cords, lungs or trachea and cause serious injury or death. According to the FDA, Avanos received reports of 23 deaths and 60 injuries, as of 2015, all linked to the FDA's use of the Cortrak*2 system to guide the installation of a feeding tube.

Cortrak 2 eternal access system The most common injuries are respiratory failure, lung collapse, lung infection, pleural effusion, and holes in the lungs' walls as well as the esophagus and bowel.

According to FDA in its March 21 Field Correction Notice, the Georgia-based company reminded users to "confirm the placement of nasogastric (and nasoenteric) tubes in accordance with the institution's policy." Cortrak 2 eternal access system The company also asked users to attach the safety notice to the operating manual for the system and to confirm with Avanos that they have received the update.

Cortrak 2 eternal access system Avanos announced that it will shortly release a new labeling system for the device, which will include a direction to map out the tube's location in accordance with their facility's policies before using the system to help install the tube.

This is the FDA's second warning regarding enteral feeding tube use. The FDA issued an entry-level safety message in February, advising healthcare professionals and parents of the potential for strangulation of children who feed tubes.

Avanos Medical feeding tube In the wake of two deaths in 2021, the notice was issued. In both cases the tubing device was found to have been inadvertently wrapped around necks of patients who were less than 2 years old when they were not supervised by their caregivers or hospital personnel.

"While FDA believes strangulation of children with enteral feeding tubes is uncommon in children, caregivers and healthcare providers should be aware that such events can and will occur," the FDA said in the notice. Cortrak 2 eternal access system They also suggested that the FDA might not have received reports on similar cases.

Avanos Medical feeding tube
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