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Class I Recall of Malfunctioning Ventilators

Nicholas Wills4 years ago

The FDA announced a Class I recall of Care Fusion EnVe Ventilators, Model 19250-001, because of interruption in the ventilation system.   

About the Care Ventilation System

The CareFusion EnVe Ventilator is a portable ventilator used to provide breathing assistance to pediatric and adult patients in hospital and medical transport settings. EnVe Ventilators were manufactured between December 2010 and January 2012.

About the EnVe Ventilator Recall

CareFusion had identified potential risks associated with the EnVe Ventilator, and decided to recall the system. A leak may occur in the patient breathing circuit or the system, resulting in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously. The device will activate both audible and visual alarms to notify the health care professional that ventilation delivery to the patient may be compromised. The alarm indicates whether delivery of ventilation to the patient has been compromised.

Class I Recall

A Class I recall is defined as having a reasonable probability of serious adverse health consequences or death associated with use of the defective units.


CareFusion is contacting facilities to coordinate hardware and software updates for affected ventilators.

Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.



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