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The FDA is aware that Ventec, doing business as React Health, has issued a letter to affected customers recommending certain VOCSN V+Pro units be removed from where they are used or sold due to a manufacturing process deviation that may result in an undetected oxygen leak condition.
Due to a manufacturing test configuration error, certain devices may not have been evaluated under all intended high-pressure conditions during production testing. As a result, an oxygen leak condition could occur that may lead to out of specification FiO₂ delivery prior to or during ventilation.
If an oxygen leak occurs, delivered FiO₂ may be reduced below intended levels. In oxygen-enriched environments, a leak could also increase fire risk. These conditions could potentially result in serious patient injury or death.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact React Health at 844-698-6276.
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