FDA Publicizes Recall of React Health Ventilators

The FDA has issued a release stating 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.”

The FDA recommends that people “identify and stop use of affected devices. Use a non-affected ventilator for patient support."

A letter sent by React Health in March urged all affected customers to “immediately discontinue use of affected VOCSN V+Pro,” as well as “inspect current stock” and “remove affected devices from clinical service.” It also urged those who “distributed or transferred affected devices to other facilities, caregivers, or end users” to “promptly notify them of this recall.”

The affected devices are being removed due to a “manufacturing process deviation that may result in an undetected oxygen leak condition.” 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.” This could “potentially result in serious patient injury or death.”