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| Hudson RCI Lifesaver disposable manual ventilator--Courtesy of Teleflex |
Teleflex Medical ($TFX) is in the process of recalling 9,333 units of its Hudson RCI manual ventilator for emergency resuscitation because "the intake port may be blocked which can cause the bag to fail to fill," according to the FDA's recall database.
It's designated as a Class 1 recall, meaning the agency believes there is a reasonable probability that the use of or exposure to the violative units "will cause serious adverse health consequences or death."
According to the FDA, Teleflex sent customers a recall notification letter on May 14, 2015, asking them to suspend distribution and quarantine the affected units.
The devices are distributed throughout the U.S. as well as Australia, the Bahamas, Canada, Guatemala and Mexico.
"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 ventilatory failure or insufficiency," the FDA said.
On the product website, Teleflex says the Hudson RCI meets ISO resuscitation bag standards. The device has variations for use on adults, pediatrics or neonates. The North Carolina company also sells a reusable version of the device, which is not affected by the recall, as well as a variety of other accessories for resuscitation, including stand-alone bags and emergency mask kits.
Airway management is a focus area of the company going forward. "We intend to develop and commercialize products that will eliminate airway-related complications," said Teleflex COO Liam Kelly during the company's May analyst day.
- here is the FDA's notice from its recall database