Teleflex Medical of Research Triangle Park, N.C., recalled its Hudson RCI Lifesaver Single Patient Use manual resuscitator.
The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device used to provide temporary breathing support for patients during periods of acute ventilatory failure. The primary users of this device are hospitals and clinics and the patient population includes infants and children.
The oxygen intake port may be blocked, which can prevent the bag from filling. This may prevent the device from delivering breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.
Teleflex sent an urgent medical device recall letter to customers asking them to immediately discontinue use and quarantine the recalled product. Hudson RCI Lifesaver Single Patient Use manual resuscitators subject to the recall were manufactured and distributed from June 2014 to April 2015.
2,405 devices were recalled in the U.S.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, February 2013 Report: Emergency Medical Services: Liability and Immunity for Medical Rescue
See also Medical Law Perspectives, December 2012 Report: When Urgency Leads to Errors: Liability for Emergency Care