Ventlab Manual Resuscitators have been recalled due to a faulty valve. The duckbill valve inside the resuscitator may stick and prevent air from getting through the valve and to the patient. If a patient does not receive oxygen or treatment is delayed, life-threatening health consequences including inadequate oxygen supply to the tissues (hypoxia) and too shallow or too slow breathing (hypoventilation) as well as death may occur.
The Ventlab Manual Resuscitator is a disposable device used to provide temporary support to patients who cannot breathe on their own. The device should only be used by personnel trained in CPR procedures and is primarily used in hospitals, clinics, and by emergency personnel.
The Ventlab Manual Resuscitator is sold under a number of names including Airflow Bag, Breath Tech Bag, Provider Bag, STAT-Check Bag, Safe Spot Bag, V-Care Bag, Medline Bag, RescuMed Bag, and VT1000 Kit. The affected recalled devices were manufactured and distributed from January 10, 2013 through July 1, 2013.
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 FDA 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, When Urgency Leads to Errors: Liability for Emergency Care