Notes

Avanos Medical is being recalled for its feeding tube system that was implicated in 23 deaths between the years 2015 and 2015.

The FDA has given its most severe warning regarding the recall of Avanos Medical's Enteral Feeding Tube Positioning System.

Avanos Mediacal Cortrak 2 feeding tube placement Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also comes with a monitor for display. In combination it provides an immediate stream of the medical feeding tube being placed in the stomach of the patient.

https://myclc.clcillinois.edu/web/jeff_test/ttttttutoring/-/message_boards/message/40995072 Avanos announced an earlier year to all Cortrak*2 devices that were used between January 2021 to January 2022. Avanos Mediacal Cortrak 2 This totaled nearly 630 devices. The devices were distributed for the first time from April 2016 until the beginning of the year.

The incident that caused the safety issue is not a reason to issue a recall. Avanos has asked healthcare providers not to send the devices back to the manufacturer. Avanos only wants to make sure that the devices are being utilized correctly.

An incorrectly placed feeding tube can damage vocal cords and the lungs. It may also cause serious injury or even death. feeding tube placement Avanos was notified of 23 deaths and 60 injuries in the year 2015 by the FDA. The incidents were all linked to the Cortrak*2 system, which guides the placement of the feeding tube.

The injuries reported include respiratory failure and lung infections, collapsed lung as well as pleural effusion. holes in the walls of the lungs, esophagus and bowel.

According to the FDA, the Georgia-based company reminded users in its March 21 field notice to "confirm the use of tubs in nasogastric/nasoente to the institution's policies". Avanos also requested that users include the safety warning and confirm with Avanos they have been updated.

Avanos has announced that they will shortly issue new labels for the product. This will include direction for locating a tube according their facility policies.

The FDA has issued a second caution regarding the use of an enteral tube for feeding use. In February, the FDA released an safety announcement warning healthcare providers and parents of the possibility of strangulation when children use feeding tubes.

The announcement came in the wake of two deaths reported in 2021. In both cases the tubing device was discovered to be accidentally wrapped around necks of patients who were less than 2 years old while they were not being monitored by their caregivers or hospital personnel.

Cortrak 2 eternal access system "While the FDA believes that death or serious injury caused by strangulation from enteral feeding set tubing for children is extremely rare Healthcare professionals and their caregivers need to be aware that such events could and do happen," the agency said in its notice and suggested that similar incidents may not have been reported to the FDA.


Read More: https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement