Teleflex Medical is in the middle of a Class 1 recall-meaning the FDA believes there is a reasonable probability that the use of or exposure to the affected units "will cause serious adverse health consequences or death."
The device in question is the Hudson RCI manual ventilator for emergency resuscitation.
According to the FDA, "the Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilator failure or insufficiency.
Teleflex is recalling 9,333 units because "the intake port may be blocked which can cause the bag to fail to fill," according to the FDA's recall database.
In response, the company said that airway management will be the focus of moving forward. ""We intend to develop and commercialise products that will eliminate airway-related complications," said Teleflex COO Liam Kelley.
The devices are distributed throughout the US, as well as in Australia, the Bahamas, Canada, Guatemala, and Mexico.