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Safety

Recall -- Firm Press Release

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Carefusion Provides Update on Voluntary Global Recall of Avea® Ventilator

Contact:
Consumer:
888-562-6018

Technical Support:
888-231-2466

Media:
Troy Kirkpatrick
(858) 617-2361
Email: troy.kirkpatrick@carefusion.com

FOR IMMEDIATE RELEASEMay 27, 2015San Diego, CA — 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 1.888.562.6018 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 1.800.231.2466 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 CodeCountry
ALAlbania
ASAmerican Samoa
ARArgentina
AUAustralia
ATAustria
BHBahrain
BDBangladesh
BBBarbados
BEBelgium
BZBelize
BMBermuda
BOBolivia
BABosnia and Heherzegowina
BRBrazil
CACanada
CLChile
CNChina (People's Rep)
COColombia
CRCosta Rica
HRCroatia
CYCyprus
CZCzech (Rep)
DODominican Republic
ECEcuador
EGEgypt
SVEl Salvador
SVEl Salvador
EEEstonia
FRFrance
GEGeorgia
DEGermany
GBGreat Britain
GRGreece
GTGuatemala
HNHonduras (Rep)
HKHong Kong, China
HUHungary (Rep)
INIndia
IDIndonesia
IEIreland
ILIsrael
ITItaly
JPJapan
JOJordan
KRKorea (Rep)
KWKuwait
LVLatvia
LBLebanon
LYLibyan Jamahiriya
LTLithuania
MYMalaysia
MXMexico
MDMoldova (republic of)
KRKorea (Rep)
KWKuwait
MAMorocco
NPNepal
NLNetherlands
NlNicaragua
NONorway
OMOman
PKPakistan
PSPalestine
PAPanama (Rep)
PYParaguay
PEPeru
PHPhilippines
PLPoland
PTPortugal
PRPuerto Rico
QAQatar
RORomania
RURussian Federation
RWRwanda
SASaudi Arabia
SGSingapore
SKSlovakia
SISlovenia
ZASouth Africa
ESSpain
TWTaiwan
THThailand
TNTunisia
TRTurkey
AEUnited Arab Emirates
UKUnited Kingdom
UYUruguay
USUnited States
VEVenezuela
VNVietnam
YEYemen

About CareFusion

CareFusion, a BD company, serves the health care industry with products and services that help hospitals measurably improve the safety and quality of care. The company develops industry-leading technologies including Alaris® infusion pumps and IV sets, MaxPlus® and MaxZero™ IV connectors and sets, Pyxis® automated dispensing and patient identification systems, AVEA®, LTV® series and AirLife® ventilation and respiratory products, ChloraPrep® products, MedMined® services for data mining surveillance, V. Mueller® surgical instruments, and an extensive line of products that support interventional medicine. For more information please visit www.carefusion.com.

About BD

BD is a leading medical technology company that partners with customers and stakeholders to address many of the world’s most pressing and evolving health needs. Our innovative solutions are focused on improving medication management and patient safety; supporting infection prevention practices; equipping surgical and interventional procedures; improving drug delivery; aiding anesthesiology and respiratory care; advancing cellular research and applications; enhancing the diagnosis of infectious diseases and cancers; and supporting the management of diabetes. We are more than 45,000 associates in 50 countries who strive to fulfill our purpose of “Helping all people live healthy lives” by advancing the quality, accessibility, safety and affordability of healthcare around the world. In 2015, BD welcomed CareFusion and its products into the BD family of solutions. For more information on BD, please visit www.bd.com.

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Page Last Updated: 05/27/2015
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