Medical technology company
) 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
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.
Becton, Dickinson and Company
) in certain niches. CareFusion currently retains a Zacks #3 Rank,
which translates into a short-term Hold rating.
BAXTER INTL (BAX): Free Stock Analysis Report
BECTON DICKINSO (BDX): Free Stock Analysis
CAREFUSION CORP (CFN): Free Stock Analysis
OMNICELL INC (OMCL): Free Stock Analysis Report
To read this article on Zacks.com click here.