Medical technology company CareFusion has provided further updates regarding the earlier announced voluntary recall of EnVe ventilators. The voluntary recall of these ventilators applies to those manufactured between December 2010 and January 2012.
The company began the voluntary recall of its EnVe ventilators in June when it issued an urgent Recall Notification to consumers. It had identified potential risks associated with the usage of the ventilators at that time. The company’s remediation plans are underway and will be implemented at customers’ site.
The company had found that the patient breathing circuit or the system of EnVe ventilators was capable of leakage due to malfunction. This may result in the ventilator not being able to withstand the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously. The device would consequently activate audible as well as visual alarms to alert clinicians. The alarm indicates whether delivery of ventilation to the patient has been compromised.
The U.S. Food and Drug Association (FDA) classified this as a Class 1 recall. A Class 1 recall is specified as the recall of a product having a considerable probability of serious adverse health or fatal consequences associated with the use of defective units. On the positive side, there has been no instance of patient harm associated with the EnVe ventilators reported to date.
CareFusion had earlier initiated a voluntary recall of its AirLife Infant Breathing Circuit on May 29. At that time it had been found that the equipment sub-part known as an adapter manufactured between June 1, 2010, and February 3, 2012, had on occasion developed a crack during patient use. It had resulted in leakage and loss in the intended tidal volume.
Amidst safety concerns and manufacturing defects associated with its products, concerns about CareFusion’s production quality standards and capabilities have also grown. It has to be accepted that this could lead to a loss in consumer confidence and trust. The costs associated with the recalls and remediation plans is also a matter of concern for the company.
CareFusion is a medical technology company with global presence. It competes with Baxter International Inc. (BAX - Analyst Report) , Becton, Dickinson and Company (BDX - Analyst Report) and Omnicell Inc. (OMCL - Analyst Report) in certain niches. CareFusion currently retains a Zacks #3 Rank, which translates into a short-term Hold rating.