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The FDA is aware that Draeger has issued a letter to affected customers recommending certain VentStar Resus Neo hoses be removed from where they are used or sold.
Draeger stated that they have become aware of cases in which obvious cracks in the hose of the VentStar Resus Neo were detected by the users prior to use.
If a cracked hose is used, the hose may fall off or leak resulting in restricted ventilation or delayed therapy which could lead to desaturation, hypoxia, or patient death.
As of August 27, Drager has reported no serious injuries or deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Draeger at 445-224-0698 or karina.howard@draeger.com .
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