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
'/>"/>

SOURCE CareFusion
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

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:9/16/2014)... Wash. , Sept. 16, 2014 /PRNewswire/ ... a late stage development company engaged primarily ... medical isotopes for diagnostic and therapeutic applications, ... for technology related to its brachytherapy products.  ... arise from its license from Battelle, under ...
(Date:9/16/2014)... -- Russia,s pharmaceutical ... Pharma 2020 Strategy provides incentives for local producers to ... foreign markets. These trends, however, were affected by recent ... political and economic sanctions imposed on Russia ... Russia responded to the US ...
(Date:9/16/2014)... Sept. 16, 2014 Surgeons at The Children,s ... a case report the first successful use of a ... year-old boy with failing Fontan circulation to bridge him ... 3 years old, the patient received a Fontan circulation ... single ventricle. "The Fontan operation is the final planned ...
Breaking Medicine Technology:Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 2Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 3Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 4Global Medicines for Russia 213-Year-Old Boy with Failed Fontan Circulation Bridged to Transplant Using the SynCardia Total Artificial Heart, Published in Annals of Thoracic Surgery 213-Year-Old Boy with Failed Fontan Circulation Bridged to Transplant Using the SynCardia Total Artificial Heart, Published in Annals of Thoracic Surgery 3
... and PRINCETON, N.J., Jan. 31, 2011 Qforma, the leading ... health sciences industry, today announced the appointments of Ted Pine ... Michael Murphy as Software Engineer. "As Qforma ... optimize service to our pharmaceutical industry customers, we welcome the ...
... 2011 OXIS International, Inc., (OTC Bulletin Board: ... favorable final results from an initial clinical study to ... joint health formula, launched commercially in December 2010. ... statistically significant after as little as one week of ...
Cached Medicine Technology:Qforma, Leading Provider of Healthcare Analytics, Announces Three New Appointments 2Final Results from ERGOFLEX Study Show Statistically Significant Reduction in Joint Pain in as Little as One Week 2Final Results from ERGOFLEX Study Show Statistically Significant Reduction in Joint Pain in as Little as One Week 3Final Results from ERGOFLEX Study Show Statistically Significant Reduction in Joint Pain in as Little as One Week 4
(Date:9/16/2014)... Cliff Lake Dental Care is proud to announce the latest ... to join Dr. Rauchwarter's team. The team at Cliff Lake ... she will bring many benefits to the office as well ... Falls, WI. She finished dental assisting school and graduated ... assisting in the Twin Cities, Milwaukee, California and Virginia. ...
(Date:9/16/2014)... Aspen Advisors, a U.S.-based healthcare IT ... for its high morale and collaborative culture ... Firms to Work For 2014.” Consulting magazine publishes ... 10,000 consultants participating across all major industries, representing more ... conducted, and firms were ranked in six categories - ...
(Date:9/16/2014)... as part of breast conservation is the current ... (HR+) invasive breast cancer. A new study by ... that combination may not be necessary for all ... results, which Fox Chase researchers presented at the ... on Sunday, September 14, suggest that low-risk patients ...
(Date:9/16/2014)... September 16, 2014 Seven heroes who ... world will be honored in New York City on ... ), the only global recognition and funding program that ... by the media as the “Nobel Prize for Child ... created life-changing programs that benefit children in countries around ...
(Date:9/16/2014)... Los Angeles, CA (PRWEB) September 16, 2014 ... the League of United Latin American Citizens (LULAC) will ... California. LULAC’s Feria de Salud will feature free health ... Other free testing includes glucose and cholesterol levels ... screenings will be available for children under 6 years ...
Breaking Medicine News(10 mins):Health News:Cliff Lake Dental Care Announces Newest Team Member 2Health News:Aspen Advisors Earns Recognition in Consulting Magazine’s "Best Small Firms to Work For" 2Health News:Aspen Advisors Earns Recognition in Consulting Magazine’s "Best Small Firms to Work For" 3Health News:Benefit of endocrine therapy in elderly women with low risk hormone receptor positive breast cancer? 2Health News:Benefit of endocrine therapy in elderly women with low risk hormone receptor positive breast cancer? 3Health News:World of Children® Award Announces 2014 Honorees 2Health News:World of Children® Award Announces 2014 Honorees 3Health News:World of Children® Award Announces 2014 Honorees 4Health News:World of Children® Award Announces 2014 Honorees 5Health News:World of Children® Award Announces 2014 Honorees 6Health News:World of Children® Award Announces 2014 Honorees 7Health News:World of Children® Award Announces 2014 Honorees 8Health News:LULAC Hosts Second Annual Latinos Living Healthy Feria de Salud in Los Angeles 2
... BRIDGEWATER, N.J., March 16 Sanofi-aventis U.S. announced ... to Chief Science Officer/Chief Medical Officer, U.S., effective ... sanofi-aventis, U.S. As the company,s Chief Science ... establish a unified medical voice for sanofi-aventis U.S. ...
... Training and Professional Certification ProgramsKERRY, Ireland and ... leading Ireland-based provider of innovative learning solutions, ... eLearning and certification programs for the American ... the Insurance Institute of America (the Institutes), ...
... result, studies find, , , MONDAY, March 16 (HealthDay News) ... can be successfully harnessed to deliver health information to ... encouraging them to stick more closely to the treatments ... suggests. , One study explored giving teens regular ...
... (NYSE: MHS ) Chairman and CEO David ... Luncheon Address to the American Enterprise Institute,s health care ... March 18, 2009, at 12:30 p.m. Through the ... be directed at expanding the use of health information ...
... Vitamin D, but be Careful Not to Burn Cautions Tanning ... Indoor Tanning Association (ITA) is encouraging beach goers to tan ... good health, overexposure to UV light can be a dangerous ... order for tanners to get all the benefits of UV ...
... the NCCN Clinical Practice Guidelines in Oncology(TM) for Thyroid ... 14. Notable updates include a new page on Thyroid ... molecule kinase inhibitors, and revised procedures for evaluating thyroid ... of Texas M.D. Anderson Cancer Center and chair ...
Cached Medicine News:Health News:Paul Chew Appointed to sanofi-aventis U.S. Chief Science Officer/Chief Medical Officer 2Health News:Ireland's PulseLearning Inks Agreement With Leading U.S. Insurance Industry Association 2Health News:Using Music and Sports to Improve Kids' Asthma 2Health News:Using Music and Sports to Improve Kids' Asthma 3Health News:Media Advisory: Medco CEO David B. Snow Jr. To Address American Enterprise Institute: 'Health IT: Empowering Precision Medicine' 2Health News:Indoor Tanning Association Promotes Responsible Tanning for Spring Breakers 2Health News:NCCN Presents Updates to NCCN Guidelines for Thyroid Carcinoma 2Health News:NCCN Presents Updates to NCCN Guidelines for Thyroid Carcinoma 3Health News:NCCN Presents Updates to NCCN Guidelines for Thyroid Carcinoma 4
19 Gauge. Reusable. Block of 4 each....
18 gauge curved. Fine tip. Lightweight design offers precise hemostasis. Pencil design minimizes tissue trauma and induced astigmatism. Knurled handle provides a sure grip and better manipulation....
Set consist of two 23 gauge, stainless steel probes with blunt tips. Probes are 18 cm (7.0 inches) long with 30.5 cm (12 inches) of flexible tubing (O.D. - 0.60 mm, I.D. - 0.30 mm) attached onto the ...
Curved, soft flexible tip allows atraumatic entry through a retinal tear or hole for aspiration of subretinal fluids. 20 gauge x 25 mm cannula attached to 25 gauge x 6 mm tip with 13 mm flexible tubi...
Medicine Products: