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Health tech company in talks with FDA about device that may have caused injury, death

April 29, 2022

Via: Fox News

Medical technology company Avanos has issued a voluntary field correction for a vital hospital tool that may have led to injury or even death.

Avanos initially told Fox News Digital that the company is in an “ongoing dialogue” with the Food and Drug Administration (FDA) on the matter and “cannot comment,” but later added that “the FDA has not requested that Avanos conduct a product recall, and we have no expectation that it will do so.”

The Cortrak 2 Enteral Access System helps healthcare providers fit feeding tubes safely into a patient so they avoid distributing food into sensitive areas of the body.

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