The most serious type of recall, a Class I recall, has been issued for Vyaire Medical’s Resuscitation Device & Broselow Convenience Kit. A product design error could cause difficulty or an inability to disconnect the mask from the elbow of the resuscitator. This issue could lead to a delay or inability to provide a patient with necessary ventilation—thus resulting in serious injury from inadequate oxygen supply (hypoxia) or death.
The manual resuscitation devices are used together to provide constant ventilation to patients who are not breathing or cannot adequately breath on their own following placement of a tracheal or tracheostomy tube. They are operated in hospitals and acute healthcare settings.
The Class I recall affects the resuscitation devices and convenience kits that were manufactured between January 2016 and January 2017, and distributed between March 2016 and January 2017.
In the United States, 357,581 devices have been recalled.
At the beginning of the year, Vyaire Medical issued a Class I recall of a different product due to a manufacturing error.