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

0

GOOD

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:5/19/2013)... Fla. , May 19, 2013  The ... and low temperature radiofrequency (RF) energy is effective ... eliminates or reduces the need for medication 10 ... assessment presented today at the Digestive Disease Week ... Orlando, Florida . "The ...
(Date:5/18/2013)... 18, 2013 Although colonoscopy exams prevent many ... most sensitive method for detecting colorectal cancers 2 , ... cases 3 . EndoChoice ® Inc. today unveiled ... improves the accuracy of this procedure and greatly reduces ... be discussing these clinical trial results and featuring the ...
(Date:5/18/2013)... SAN FRANCISCO , May 18, 2013 /PRNewswire-USNewswire/ ... MadinAmerica.com , Occupy Psychiatry ... reform mental health care, announces a social media ... by the traditional psychiatric model, which focuses on ... The launch coincides with the American Psychiatric Association,s ...
Breaking Medicine Technology:Stretta Procedure for GERD: Successful 10 Year Follow-Up Data Presented at Digestive Disease Week--Sustained Improvement, Long-Term Efficacy 2Stretta Procedure for GERD: Successful 10 Year Follow-Up Data Presented at Digestive Disease Week--Sustained Improvement, Long-Term Efficacy 3New Study Shows Full Spectrum Endoscopy Procedure Reduces The 'Miss Rate' of Adenomas During Colonoscopy 2New Study Shows Full Spectrum Endoscopy Procedure Reduces The 'Miss Rate' of Adenomas During Colonoscopy 3New Social Media Campaign Features Stories Of Individuals Who Rejected Psychiatric Diagnoses 2New Social Media Campaign Features Stories Of Individuals Who Rejected Psychiatric Diagnoses 3
... WALTHAM, Mass. , May 20 Inverness Medical ... enabling individuals to take charge of their health at home through ... it will attend the Citi Global Health Care Conference being held ... Hilton Hotel in New York City .  Jon Russell, Vice ...
... DALLAS , May 20 As part of its ongoing commitment ... announced that it will be one of the sponsors of the Living for ... Country Club in Plano, Texas . , ... The Living for Zachary golf event is named for 16-year-old Plano ...
Cached Medicine Technology:HeartSine Technologies Supports 'Living for Zachary' Benefit Golf Tournament 2HeartSine Technologies Supports 'Living for Zachary' Benefit Golf Tournament 3
(Date:5/19/2013)... California (PRWEB) May 19, 2013 Grinding ... than just losing sleep, or annoying your spouse. At ... report by CNY Central (“Snoring and Teeth Grinding Could ... type of teeth grinding can be hard to prevent. ... million Americans, and one of its symptoms is a ...
(Date:5/19/2013)... (PRWEB) May 19, 2013 According ... Market Analysis and Forecast (2013 – 2018): By ... Defense, Industrial)); Technology (CCD, CMOS, Contact IS, Infrared, ... of image sensor market was $8.00 billion in ... in 2018, at an estimated CAGR of 3.84% ...
(Date:5/19/2013)... 6Webs.com is the leader in reviews ... are considering an alarm system can do a comparison ... security system providers online at 6Webs.com. Just recently finishing ... home security system companies, 6Webs.com currently is announcing ... home security companies before ranking the home security system ...
(Date:5/19/2013)... These molecular diagnostics market reports ... Japan, Italy, Germany and France:, ... practice, as well as key economic, regulatory, demographic, ... during the next five years. ,     An ... test formats, detection methodologies, trends in testing automation ...
(Date:5/19/2013)... 19, 2013 The report “Feed Additives ... & Forecasts up to 2017” published by MarketsandMarkets, defines ... analysis and forecasting of the global volume and revenue ... driving and restraining factors for the global market with ... challenges. The market is segmented and revenue is forecasted ...
Breaking Medicine News(10 mins):Health News:Dr. Kanani, Woodland Hills Dentist: Dangers of Tooth Damage and Obstructive Sleep Disorder 2Health News:Dr. Kanani, Woodland Hills Dentist: Dangers of Tooth Damage and Obstructive Sleep Disorder 3Health News:Image Sensors Market to Reach $10.75 Billion by 2018 at a CAGR of 3.84% - New Report by MarketandMarkets 2Health News:Image Sensors Market to Reach $10.75 Billion by 2018 at a CAGR of 3.84% - New Report by MarketandMarkets 3Health News:Top Rated DIY Home Security System Companies Published by 6Webs.com 2Health News:Molecular Diagnostics Market - US, UK, Spain, Japan, Italy, Germany & France Analysis in New Research Report at ReportsnReports.com 2Health News:Molecular Diagnostics Market - US, UK, Spain, Japan, Italy, Germany & France Analysis in New Research Report at ReportsnReports.com 3Health News:Molecular Diagnostics Market - US, UK, Spain, Japan, Italy, Germany & France Analysis in New Research Report at ReportsnReports.com 4Health News:Feed Additives Market to Reach $19.5 Billion by 2017 at a CAGR of 3.8% - New Report by MarketandMarkets 2Health News:Feed Additives Market to Reach $19.5 Billion by 2017 at a CAGR of 3.8% - New Report by MarketandMarkets 3
... sex with an infected partner, adolescent girls have a 1% ... herpes . ,Britain is facing a major teen sex ... (STIs) and high levels of teenage pregnancy in the UK ... enhance sexual activity, Independent Advisory Group (IAG) on Sexual Health ...
... Researchers at the Salk Institute for Biological Studies have found ... kind humans experience in everyday life, may contribute to ... a hallmark of Alzheimers disease. ,The researchers say ... Alzheimers disease, a number of studies have pointed to stress ...
... in patients with rheumatoid arthritis (RA) is significantly reduced ... first trimester to the third trimester of the participants ... ,This is the first prospective study ... 124 female RA patients throughout their pregnancy and at ...
... ruled that Ontario residents can get cold and allergy ... . ,The Ontario Superior Court has overturned ... Ontario College of Pharmacists preventing grocers from selling medications ... and Benadryl. ,The original decision was made ...
... the University at Buffalo conducted a content analysis of newspaper ... results for organ donation. ,In a study ... results showed that 57 percent of the articles were positive ... were neutral. ,"Research has shown that most of ...
... or more of oral steroid treatment decreases the risk of ... were found regardless of when in the course of the ... were not observed if the steroids were taken for less ... of corticosteroid treatment in rheumatoid arthritis have been a subject ...
Cached Medicine News:Health News:UK Facing Major Sexual Health Crisis Among Teens 2Health News:UK Facing Major Sexual Health Crisis Among Teens 3Health News:Emotional Stress Could Be a Factor in Causing Alzheimers: Study 2Health News:Intensity of Rheumatoid Arthritis Significantly Reduced by Pregnancy 2Health News:Canadian Court Rules Grocery Shops can Sell Cold Medications Containing Pseudoephedrine 2Health News:Newspaper Analysis positive Results for Organ Transplantation 2Health News:Long-term Oral Steroid Therapy Decreases Lymphoma Risk in Rheumatoid Arthritis 2
... chairs with concave seats and standard-sized ... options like seats, backrests, armrests, and ... are recommended for the following environments: ... control, health care and office. • ...
... Basic ergonomic chairs with concave ... support • Select options like seats, ... • BTN/1Q-CAB chairs are recommended for ... clean room, static control, health care ...
... Basic ergonomic chairs with concave seats ... • Select options like seats, backrests, ... BTN/1Q-CAB chairs are recommended for the ... room, static control, health care and ...
... concave seats and standard-sized backrests with ... seats, backrests, armrests, and casters and ... for the following environments: industry, education, ... care and office. • With cast ...
Medicine Products: