Navigation Links
CareFusion Initiates Class I Recall of EnVe Ventilators
Date:10/19/2011

SAN DIEGO, Oct. 19, 2011 /PRNewswire/ -- CareFusion (NYSE: CFN), a leading global medical device company, issued the following update regarding its recall of 128 EnVe™ ventilators affecting 29 customers. The FDA has classified this action as a Class I recall.

The voluntary recall only affects EnVe ventilators manufactured between December 2010 and May 2011 and therefore, has no affect on the company's current product production or shipping processes.

On September 12, the company sent an urgent Medical Device Recall Notification to customers stating the identified potential risks associated with the EnVe ventilators. The issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection upon transport. Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

In the notification letter, customers were provided serial numbers of affected devices. This information is available at http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-enve-ventilator.aspx.

CareFusion is conducting a field corrective action to update the hardware and software on affected ventilators. The company determined the root cause for each issue and is committed to updating each device in a timely manner with minimal disruption to customers.

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 Launches New Emergency Transport Ventilator
2. B. Braun Medical Sues CareFusion for Patent Infringement
3. CareFusion Reports Fourth Quarter and Fiscal 2011 Results
4. CareFusion and ResMed Announce Distribution Agreement for U.S. Hospital Market
5. CareFusion Will Host an Earnings Conference Call on Aug. 8 to Discuss the Results for the Fourth Quarter and Fiscal 2011
6. CareFusion to Acquire Pharmacy Automation Innovator Rowa
7. CareFusion Reports Third Quarter Rise in Revenue, Earnings
8. CareFusion Will Host an Earnings Conference Call on May 5 to Discuss the Results for the Third Quarter Fiscal 2011
9. CareFusion Acquires Technology for Sorting and Managing Dangerous Pharmaceutical Waste
10. CareFusion Announces Departure of Chief Operating Officer
11. CareFusion Completes Sale of Onsite Services Instrument Management and Repair Business
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... addition of the "Structural Electronics 2015-2025: Applications, ... In-Mold Electronics, Smart ... Integrated Photovoltaics Structural electronics involves ... as load-bearing, protective structures, replacing dumb structures such ...
(Date:6/24/2016)... According to a new market ... Needles, Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, ... of Purchase (Retail, Non-Retail) - Trends & Global Forecasts ... market for the forecast period of 2016 to 2021. ... by 2021 from USD 1.65 Billion in 2016, growing ...
(Date:6/23/2016)... , June 23, 2016 Research and ... Global Market - Forecast to 2022" report to their ... treatment method for the patients with kidney failure, it replaces ... fluid from the patient,s blood and thus the treatment helps ... and chloride in balance. Increasing number of ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/26/2016)... ... , ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a ... fitness app plans to fix the two major problems leading the fitness industry today:, ... type program , They don’t eliminate all the reasons people quit their exercise ...
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due ... up a new, often overlooked aspect of head lice: the parasite’s ability to live away ... a common occurrence, but a necessary one in the event that lice have simply gotten ...
(Date:6/25/2016)... , ... June 25, 2016 , ... First Choice ... States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm ... Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical ...
Breaking Medicine News(10 mins):