Illinois users of two medical devices — a manual resuscitator and a ventilator — may take notice of recent Class I Food and Drug Administration recalls. In both cases, a defective product had the potential to cause harm to customers.
In the first case, the Ventlab manual resuscitator for adults and children was recalled due to a leaking valve that may deliver little or no air or oxygen to a patient during its use. The FDA said the lack of airflow may not be seen by users because the bag deflates just as it normally would when compressed. Emergency personnel often use the product when transferring patients and as backups for other ventilators and anesthesia machines.
From its headquarters in Mocksville, North Carolina, last July, Ventlab announced a voluntary recall of more than 14,600 of the manual resuscitators. The units being recalled had been manufactured and then distributed between March and July 2012.
In the second recall, Bunnell of Salt Lake City issued an “urgent” recall notice for its Life Pulse High-Frequency Ventilator Patient Circuits. According to the FDA, wire insulation on the product can melt and cause sparking and smoke close to the humidifier cartridge. The devices are used with critically ill infants and infants with respiratory syndromes.
Bunnell sent its recall notice to customers in November for products distributed between mid-March and Nov. 1, 2012.
When treatment of a patient’s medical condition relies on a medical device, any defect or hazard can present a serious liability for a manufacturer if it is proven negligent or the product directly causes injuries or death.
The injured party may have the right to receive compensation to meet medical, therapy and other necessary expenses. The compensation from medical products liability cases varies by the situation and the state. It may continue until a victim achieves complete recovery.
Source: Medpagetoday.com, “Ventilator Products Recalled,” Chris Kaiser, Dec. 26, 2012