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Two Defective Ventilator Products Recalled by FDA
A ventilator is a machine that assists people who are unable to breath by mechanically supplying oxygen and pulling out poisonous carbon dioxide. They can usually be found in intensive care units, emergency rooms, and when receiving healthcare at home. They can also be used during surgery for people who are under anesthesia, in case their heart is slowed too much. There are also manual units which are pumped during activities like CPR.
Given the uses of ventilators, the FDA has issued the highest class of recalls for two ventilator products. A Class I recall signifies that a medical product may cause serious injuries or death.
Ventlab, a corporation which manufactures ventilator products, had one of their manual units recalled by the FDA. The recall affects ventilators made during March and July of 2012. There is a defective valve which prevents patients from receiving oxygen, even though the bag inflates. Failures of this ventilator could lead to life-threatening situations including hypoxia, hypoventilation, and even death. This recall is on the heels of Ventlab issuing their own voluntary recall in July.
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