Notes

Avanos Medical faces a Class I recall over feeding tube system connected to 23 deaths in 2015

After seven years during which Avanos Medical's intravenous tube placement device was plagued by unlucky luck and mishaps, the FDA has issued the most important instructions to recall the product.

Avanos Medical feeding tube The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and an LCD monitor. In combination this system allows you to view the actual placing of a medical feeding tube in a patient's stomach.

Avanos initiated a recall earlier in this year for every Cortrak*2 piece of equipment that was that was used between January 2021 to Jan 2022. There were 630 units originally distributed from April 2016 to the beginning.

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The incident of safety isn't a recall. Avanos doesn't ask healthcare providers to return the devices, but to ensure that they use them properly.

Incorrectly inserting the feeding tube incorrectly can cause harm to vocal cords and lungs. Avanos has reported the number of injuries to patients and deaths to patients in the last year, FDA stated. https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges All of them were directly related to FDA's Cortrak*2 system that is used to insert a feeding tube.

The most common injuries include respiratory failure and collapsed lung infected lung, as well as holes in the walls the esophagus and lungs.

Cortrak 2 eternal access system In the field correction notice of March 21, notice, the Georgia-based company advised users to "confirm the use of nasogastric or Nasoenteric tubes as per the policies of the institution," per the FDA. Avanos has asked patients to add a safety warning to their operating manuals and verify they have been updated.

Avanos announced that they will soon issue an updated labeling for the device. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its It will include the instructions for placing a tube according to their policies.

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The FDA has issued a second warning regarding feeding tubes for enteral nutrition. In February, the agency issued a safety message informing healthcare professionals and parents about the danger of strangulation for children using tubes for feeding.

The announcement followed two instances of deaths in 2021. In both instances the tubing system was discovered to be wrapped around the neck of patients younger than 2 while they weren't being directly watched by the medical staff or caregivers.

"The FDA believes that death and serious injuries resulting due to strangulation caused by enteral feeding set tubing for children is extremely rare. However, healthcare professionals and their caregivers should be aware of the possibility that these incidents can and do happen," the FDA said in the notice. Avanos Medical feeding tube The agency suggested that similar incidents could not yet be reported to the FDA.


Read More: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its