Notes

Avanos Medical faces Class I recall for feeding tube system implicated in 23 deaths in 2015

After seven years' of failure for Avanos Medical, Avanos Medical’s Enteral Feeding Tube Placing System, the FDA has issued the most severe recall order.

https://aacnjournals.org/ajcconline/article/26/2/149/3230/Cortrak-Assisted-Feeding-Tube-Insertion-A Cortrak*2 Enteral Access System contains an electromagnetic stylet as well as an external receiver. Avanos Medical feeding tube When they are used together it provides a live feed of the positioning of a medical feeding tube into a patient's stomach or small bowel, with the intention of improving the accuracy of the tube's tip positioning and reducing the risk of complications.

Avanos started the recall earlier this year for the entire Cortrak*2 device that was used between January 2021 to Jan 2022. There were nearly 630 devices originally distributed between April 2016 to the beginning.

https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding RELATED
A tiny, unassuming widget that promises greater security, can cause chaos for tube feeders
The safety incident is not an recall. Avanos doesn't ask healthcare providers send the devices back, but to ensure that they use them correctly.

A wrongly placed feeding tube can cause harm to vocal cords as well as lungs. It can also result in serious injury or even death. According to FDA, Avanos received reports of 23 deaths, and 60 injuries, as of 2015, all related to the FDA's use of the Cortrak*2 system to guide the placement of the feeding tube.

A few of the injuries that have been reported include respiratory failure and collapsed lung infected lung, as well as holes in the walls the lungs and esophagus.

In its March 21 field correction note, the Georgia-based business warned users to "confirm placement of nasogastric and nasoenteric tubes according to guidelines of the institution" according to the FDA. Avanos asked users to add the safety announcement to the system's operation manual and then confirm that they have notified Avanos that the update was received.

Avanos said it would soon issue updated labels for the device. These will include the direction of where to put the tube, according to their policies.

RELATED
FDA requires Philips to replace, repair or reimburse all ventilators that were recalled.
The FDA has issued a second warning this year about the use of enteral feeding tubes. In February, the agency put out an safety announcement to inform healthcare professionals and parents about the danger of strangulation for children using feeding tubes.

Following two reports of deaths in 2021, a notice was issued. Cortrak 2 eternal access system In both cases the tubing system was wrapped around a child's neck when they weren't being closely watched by hospital staff or caregivers.

"The FDA believes that death or serious injury resulting caused by strangulation with tubing for feeding tubes used in the enteral system for children is uncommon. Avanos Medical feeding tube However, healthcare providers and their caregivers should be aware that such events can and do happen," the FDA said in the announcement. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery The FDA said that similar incidents might not yet have been reported to FDA.


Here's my website: https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/