CareFusion Provides Update on Voluntary Global Recall of AVEA® Ventilator

May 27, 2015

SAN DIEGO, CA, May 27, 2015 /PRNewswire/ - CareFusion, a BD company (NYSE:BDX), provided an update on a global voluntary recall that was initiated on April 21, 2015 to address an issue with certain units of AVEA® ventilators.

The recall has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA), which means the Agency believes that there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. To date, no report of patient injury has been received related to this issue.

The AVEA ventilator is only used in hospitals and other health care facilities and is intended for continuous breathing support for neonatal through adult patients. The recall is in response to a potential malfunction of an AVEA ventilator specific 5 psi pressure transducer. The affected AVEA ventilators may develop a failure mode over a period of time, where, by design, the ventilator activates false Extended High Ppeak or Circuit Occlusion audio and visual alarms, opens the safety valve and stops ventilating. If this occurs, alternate ventilation support will be required to reduce the potential of hypoxemia or hypercapnia.

The global recall involves AVEA ventilators manufactured, serviced and distributed from July 1, 2011 to March 15, 2015. CareFusion learned of this issue through customer reports identifying Extended High Ppeak or Circuit Occlusion alarms. A list of affected model and serial numbers is available at the CareFusion website. Refer to Figure 1 for the location of model and serial numbers.

CareFusion puts patient safety first and will continue to work diligently with customers and global regulatory authorities to resolve this issue in a timely manner. The company has notified customers of the recall with an urgent recall letter. The CareFusion Recall Support Center is contacting global customers via telephone to coordinate on-site AVEA ventilator correction in a timely, effective manner.

The FDA and other regulatory authorities have been notified.

Instructions to Customers

CareFusion does not require the return of affected AVEA ventilators.

In the interim, if an AVEA ventilator exhibits a sustained Extended High Ppeak or Circuit Occlusion alarm followed by the opening of the safety valve that cannot be cleared by powering the ventilator off and back on again, immediately remove the ventilator from service, provide alternate ventilation and contact CareFusion Technical Support at the contact information listed below to report the issue.

Customer inquiries related to this action should be addressed to the CareFusion Recall Support Center at 1.888.562.6018Call: 1.888.562.6018 or email SupportCenter@carefusion.com between the hours of 6:30 a.m. to 5:00 p.m. PDT.

For technical support or to report a problem, please contact CareFusion Technical Support at 1.800.231.2466Call: 1.800.231.2466 or email Support.Vent.US@carefusion.com.

Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

Countries with AVEA ventilators affected by the global recall:

ISO Code Country
AL Albania
AS American Samoa
AR Argentina
AU Australia
AT Austria
BH Bahrain
BD Bangladesh
BB Barbados
BE Belgium
BZ Belize
BM Bermuda
BO Bolivia
BA Bosnia and Heherzegowina
BR Brazil
CA Canada
CL Chile
CN China (People's Rep)
CO Colombia
CR Costa Rica
HR Croatia
CY Cyprus
CZ Czech (Rep)
DO Dominican Republic
EC Ecuador
EG Egypt
SV El Salvador
EE Estonia
FR France
GE Georgia
DE Germany
GB Great Britain
GR Greece
GT Guatemala
HN Honduras (Rep)
HK Hong Kong, China
HU Hungary (Rep)
IN India
ID Indonesia
IR Iran
IE Ireland
IL Israel
IT Italy
JP Japan
JO Jordan
KR Korea (Rep)
KW Kuwait
LV Latvia
LB Lebanon
LY Libyan Jamahiriya
LT Lithuania
MY Malaysia
MX Mexico
MD Moldova (republic of)
KR Korea (Rep)
KW Kuwait
MA Morocco
NP Nepal
NL Netherlands
Nl Nicaragua
NO Norway
OM Oman
PK Pakistan
PS Palestine
PA Panama (Rep)
PY Paraguay
PE Peru
PH Philippines
PL Poland
PT Portugal
PR Puerto Rico
QA Qatar
RO Romania
RU Russian Federation
RW Rwanda
SA Saudi Arabia
SG Singapore
SK Slovakia
SI Slovenia
ZA South Africa
ES Spain
TW Taiwan
TH Thailand
TN Tunisia
TR Turkey
AE United Arab Emirates
UK United Kingdom
UY Uruguay
US United States
VE Venezuela
VN Vietnam
YE Yemen

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com

For more information on BD, please visit bd.com.

Troy Kirkpatrick

858 617 2361
Email Troy

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