BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

CareFusion Corporation Recalls Infant Breathing Product


7/3/2012 9:01:10 AM

SAN DIEGO, July 2, 2012 /PRNewswire/ -- CareFusion issued the following update regarding its voluntary recall of its AirLife Infant Breathing Circuit. The FDA has classified this action as a Class 1 recall.

The company initiated the voluntary recall on May 29. The products subject to the recall were manufactured between June 1, 2010, and Feb. 3, 2012. This action has no effect on the manufacture or distribution of current products.

In May 2012, the company sent an urgent Recall Notification to customers and distributors stating the identified potential risks associated with the AirLife Infant Breathing Circuit. The Y-adapter in affected products could develop cracks during patient use, potentially resulting in a leak in the closed ventilation system and leading to a loss in the intended tidal volume delivered to the patient. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units. To date, there have been no reports of patient harm associated with the affected products.

There is no change to the remediation plans previously announced by the company. In the notification letter, customers were provided lot numbers of affected product codes and asked to destroy any affected products remaining in inventory. This information is available at http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-for-airlife-infant-breathing-circuit.aspx.

Since the recall was initiated in May, nearly half of the affected customers and distributors have completed the remediation process.

Instructions to customers
Customer inquiries related to this action should be addressed to CareFusion Customer Service at Customer.Experience@carefusion.com.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program: by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; by phone at 1-800-332-1088; by fax at 1-800.FDA.0178 or at www.fda.gov/medwatch.

Additional product recall information

CareFusion has posted on its website information regarding the AirLife product recall and other product recalls and alerts. Also today, the company separately filed with the Securities and Exchange Commission a Form 8-K in which the company reported an expected increase to its recall reserve of approximately $7 million for the quarter and fiscal year ended June 30, 2012. This adjustment is primarily related to a voluntary recall affecting the PC unit of certain models of the company's Alaris® infusion pumps. More information can be found on the company's website at http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-alaris-8015.aspx.

About CareFusion
CareFusion (NYSE: CFN) is a global corporation serving the health care industry with products and services that help hospitals measurably improve the safety and quality of care. The company develops market-leading technologies including Alaris® infusion pumps, Pyxis® automated dispensing and patient identification systems, AVEA®, AirLife and LTV® series 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. CareFusion employs more than 14,000 people across its global operations. More information may be found at www.carefusion.com.

SOURCE CareFusion



Read at BioSpace.com
Read at Reuters
Read at News Release

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES