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:10/11/2017)... Oct. 11, 2017  BioPharmX Corporation (NYSE MKT: BPMX) ... developed an innovative way to use nonlinear optical imaging ... of new drugs. ... Conference will show how researchers from BioPharmX and the ... School used a suite of imaging techniques in what ...
(Date:10/10/2017)...  NDS received FDA 510(k) clearance in May 2017 for its ... specifically designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... to support the improvement of patient outcomes, procedural efficiency, and the ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
Breaking Medicine Technology:
(Date:10/12/2017)... Francisco, CA (PRWEB) , ... October 12, 2017 ... ... Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus O2Vent ... apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral appliances ...
(Date:10/12/2017)... Fla. (PRWEB) , ... October 12, 2017 , ... IsoComforter, ... therapy products, announced today the introduction of an innovative new design of the shoulder ... pad so you get maximum comfort while controlling your pain while using cold therapy. ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information about the technology: , ... to enable prevention of a major side effect of chemotherapy in children. Cisplatin ... patients. For cisplatin, hearing loss is FDA listed on-label as a dose limiting ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts ... Washington, D.C., for the 49th Congress of the International Society of Paediatric Oncology ... of the Center for Cancer and Blood Disorders at Children’s National, and ...
(Date:10/12/2017)... ... , ... Health Literacy Innovations (HLI), creator of the Health ... Cancer Patient Education Network (CPEN), an independent professional organization that shares best practices ... , As CPEN’s strategic partner, HLI will help support CPEN members by ...
Breaking Medicine News(10 mins):