Notes

Avanos Medical faces Class I recall because of feeding tube system connection to 23 deaths.

After seven years of Avanos Medical's tube placement device was struck by unlucky luck, the FDA handed out its most severe directive for a recall.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and a display monitor. Avanos Medical The system can be used in conjunction to stream a live video that illustrates the process of inserting a feeding tube in the stomach of a patient. The procedure is performed with the aim of improving the accuracy of the procedure and decreasing complications.

Despite that goal, however, the system has been implicated in dozens of patient injuries, leading Avanos to issue an recall in January of all Cortrak*2 devices used between January 2021 and January 2022--totaling more than 630 devices that were distributed between April 2016 until the beginning of this year.

feeding tube placement The safety event is not recall in its true sense: Avanos does not ask health professionals to return the devices to the manufacturer. Instead, it wants to ensure users are using the devices correctly.

http://spectr-sb116.ru/user/Avanos.Mediacal.Cortrak.2wxjz333/ Incorrectly inserting a feeding tube could result in damage to the vocal cords, lungs, or trachea. This could result in severe injury or death. Avanos has reported the number of injuries to patients and deaths to patients in 2015, the FDA said. All of them directly related to FDA's Cortrak*2 system that is used to insert the feeding tube.

These injuries could include respiratory failure, collapsed lungs, lung infections, and holes within the lung's walls and esophagus.

According to FDA in the March 21 Field Correction Notice the Georgia-based business reminded users to "confirm placing of nasogastric (and nasal) tubes according to institutional policy." They've also been instructed to attach the safety warning to the operating manual for the system and verify with Avanos that they received the latest version of the notice.

Avanos has announced that they will soon issue a new label for the product. Avanos Medical feeding tube This will include the direction for locating a tube according to their facility's policies.

This is the FDA's second warning regarding feeding tubes for enteral nutrition. In February, FDA issued a safety advisory to healthcare providers and parents regarding the dangers of strangulation in children using feeding tubes.

feeding tube placement Two deaths occurred in 2021 and were reported to the notice. In each instance the tubing system was found to be wrapped around the neck of patients younger than 2 when they weren't directly monitored by medical staff or caregivers.

"While FDA believes that death from strangulation using enteral feeding tubing used for children is uncommon but it is important that caregivers and healthcare professionals are aware that events like this occur," the FDA stated in its notice. Avanos Medical feeding tube The FDA suggested that similar cases may not have been reported.


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