Navigation Links
CareFusion Provides Update on Previously Announced Ventilator Recall
Date:12/22/2011

SAN DIEGO, Dec. 22, 2011 /PRNewswire/ -- CareFusion issued the following update regarding the voluntary recall of AVEA® ventilators it initiated in September. The FDA has now classified this action as a Class I recall.

There is no change to the remediation plans previously announced by the company and CareFusion is actively remediating the hardware on affected units. The recall affects AVEA ventilators and spare parts manufactured between March 1, 2009 and June 30, 2011 and therefore has no affect on the company's current production or shipping processes.

In September 2011, the company sent an urgent Medical Device Recall Notification to customers stating the identified potential risks associated with AVEA ventilators. Affected units may produce an extended high Ppeak alarm, which initiates audio and visual alarms, followed by the opening of the safety valve. No breaths are delivered during this alarm condition, instead the safety and exhalation valves open allowing the patient to breathe from room air and activating the safety valve alarm. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

The company had determined the root cause for the issue and is committed to updating each device in a timely manner with minimal disruption to customers. More information about the recall is available at: http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-avea-ventilator.aspx.

The company recorded a reserve in its 2012 fiscal first quarter related to this recall and continues to believe the amount to be sufficient to fulfill its remediation obligations.

Instructions to customers
Customer inquiries related to this action should be addressed to CareFusion Technical Support at 800-554-8933.

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.

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, Nicolet™ neurological monitoring and diagnostic products, 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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CareFusion Showcases Medication Management Technologies at American Society for Health-System Pharmacists Conference
2. CareFusion Launches Wireless Diagnostic and Monitoring Neurological Device
3. CareFusion Announces New Ventilation Solution to Help Hospitals Provide Improved Patient Care and Reduce Costs
4. CareFusion Initiates Class I Recall of EnVe Ventilators
5. CareFusion Launches New Emergency Transport Ventilator
6. B. Braun Medical Sues CareFusion for Patent Infringement
7. CareFusion Reports Fourth Quarter and Fiscal 2011 Results
8. CareFusion and ResMed Announce Distribution Agreement for U.S. Hospital Market
9. CareFusion Will Host an Earnings Conference Call on Aug. 8 to Discuss the Results for the Fourth Quarter and Fiscal 2011
10. CareFusion to Acquire Pharmacy Automation Innovator Rowa
11. CareFusion Reports Third Quarter Rise in Revenue, Earnings
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2017)... 2017  A new tight-tolerance microextrusion medical tubing ... materials, is being launched by Natvar, a Tekni-Plex ... in recent years to service a wide variety ... More expensive materials such as glass and fluoropolymers ... to their ability to consistently hold tolerances. This ...
(Date:5/3/2017)...  Getinge, a leading global provider of products ... cost efficiency within healthcare and life sciences, today ... demonstrating that intra-aortic balloon counterpulsation (IABC) appears effective ... The single-center, retrospective, observational study showed that use ... 50cc intra-aortic balloon (IAB) in contemporary practice ...
(Date:5/2/2017)...  CIVCO Radiotherapy, the leading provider of high ... Nat Geissel has been named president. ... has served as vice president of marketing and ... manager, and most recently, executive vice president and ... of what CIVCO Radiotherapy and its predecessors have ...
Breaking Medicine Technology:
(Date:5/19/2017)... , ... May 19, 2017 , ... ... health community, Queens University of Charlotte recently began recruitment efforts for the inaugural ... arms students with the skills, knowledge and expertise to approach and address the ...
(Date:5/19/2017)... (PRWEB) , ... May 19, 2017 , ... When Kyle ... 20, his name will already appear on two major research studies that could impact ... working with Dr. Matt Daggett, KCU alumnus and an orthopedic surgeon, alongside an international ...
(Date:5/19/2017)... ... 2017 , ... The Hill Agencies, a family managed firm that offers insurance ... Valley, is announcing a joint charity initiative with the Boys and Girls Club of ... event. , The Boys and Girls Club of Kern County gives young people in ...
(Date:5/19/2017)... ... May 19, 2017 , ... ... of Beckman Young Investigators: , Victor Acosta, Ph.D. - University of New Mexico, ... Fu, Ph.D. - University of Washington, Erik Grumstrup, Ph.D. - Montana Stata University, ...
(Date:5/19/2017)... ... , ... As a groundbreaking surgeon on the frontline of prostate cancer treatment, ... detection of the disease, he says, can make a world of difference. ... alongside the Georgia Comprehensive Cancer Control’s (GC3) Prostate Cancer Task Force and its suggestion ...
Breaking Medicine News(10 mins):