Navigation Links
CareFusion Recall of Alaris PC Units Model 8015 Classified as Class I Recall
Date:10/15/2010

SAN DIEGO, Oct. 15 /PRNewswire/ -- CareFusion (NYSE: CFN), a leading, global medical device company, issued the following update regarding its previously disclosed recall of approximately 17,000 Alaris® PC units model 8015 manufactured or serviced between December 2008 and September 2009. The FDA has classified this action as a Class I recall. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

On August 24, 2010, the company sent an urgent Medical Device Recall Notification to customers of its Alaris PC unit model 8015 stating that under certain wireless network conditions, affected units may experience an intermittent communication error, which freezes the PC unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions. If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down with a delay in therapy, which could lead to a serious injury or death.

In the notification letter, customers were provided clinical tip sheets and informed of warning tags for each of the affected units. Customers were also given instructions on how to temporarily or permanently disable the wireless mode of the PC unit setting to further mitigate the risk. This information is available at: http://www.carefusion.com/customer-support/alerts/alaris/medical-device-recall-alaris-8015.aspx

CareFusion is conducting a field corrective action to update the hardware on affected PC units.

The company recorded a reserve in its 2010 fiscal fourth quarter for all actions related to the corrective action plan and continues to believe the amount to be sufficient to fulfill its remediation obligations. The voluntary recall only affects Alaris PC units model 8015 manufactured or serviced between December 2008 and September 2009 and therefore, has no affect on the company's current infusion pump production or shipping processes.

Instructions to customers

Customer inquiries related to this action should be addressed to the CareFusion recall center at 888-562-6018. Additional information about the recall, including serial numbers of affected devices, can be found at http://www.carefusion.com/customer-support/alerts/alaris/medical-device-recall-alaris-8015.aspx

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® IV pumps, Pyxis® automated dispensing and patient identification systems, AVEA®, AirLife™ and LTV® series ventilation and respiratory products, ChloraPrep® products, MedMined™ services for infection surveillance, NeuroCare neurological monitoring and diagnostic products, V. Mueller® surgical instruments, and an extensive line of products that support interventional medicine. CareFusion employs more than 15,000 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 Expands Skin Antisepsis Portfolio
2. CareFusion and Blue Cross and Blue Shield of Illinois Create Illinois Hospital Quality Initiative to Help Eliminate Health Care-Associated Infections
3. CareFusion Announces National Launch of Spinal Fracture Device
4. CareFusion Will Host an Earnings Conference Call on Aug. 10 to Discuss the Results for the Fourth Quarter and Fiscal 2010
5. CareFusion Launches First Automatic Oxygen Controller to Improve Care for Newborns Needing Mechanical Ventilation
6. CareFusion Completes Medegen Acquisition
7. CareFusion Announces Agreement With Banner Health to Upgrade and Extend Pyxis Medication Solutions
8. CareFusion, Cerner to Integrate Technologies for Improved Hospital Safety, Efficiency
9. CareFusion Will Host an Earnings Conference Call on May 6 to Discuss the Results for the Third Quarter of Fiscal 2010
10. CareFusion Launches New Pyxis ProcedureStation(TM) Radio Frequency Identification System at Association of Perioperative Registered Nurses 57th Annual Congress
11. CareFusion Sponsors Global Summit of Patient Safety Leaders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... NEW YORK and GENEVA ... Agreement announced on World Tuberculosis Day revitalizes efforts to ...   On World Tuberculosis Day, TB Alliance ... agreement for the clinical development of sutezolid, an antibiotic ... The sublicense pertains to the development of sutezolid in ...
(Date:3/23/2017)... The key factors driving the growth ... accelerating economic growth and increasing healthcare expenditure. Some of the ... expectancy of ESRD patients, rising demand for home PD treatment ... of the market is hindered by high treatment costs and ... ...
(Date:3/23/2017)... INDIANAPOLIS , March 23, 2017  Eli Lilly ... William Sansum Diabetes Center have established a research collaboration ... diabetes through enhanced research, education and care. ... bears a disproportionate weight on Latino families in ... Kerr , M.D., FRCPE, director of Innovation and Research ...
Breaking Medicine Technology:
(Date:3/24/2017)... MI (PRWEB) , ... March 24, 2017 , ... ... assistance, financial planning, and related services to families and business owners across eastern ... aimed at feeding regional families struggling with financial difficulties. , The Oxford/Orion FISH ...
(Date:3/24/2017)... ... 24, 2017 , ... Northridge dentists, Dr. Michel ... sleep apnea and TMJ at their office. TMJ, or temporomandibular joint disorder, has ... type, is increasingly being treated at dental offices with newly developed procedures and ...
(Date:3/24/2017)... , ... March 24, 2017 , ... ... http://www.hygieacare.com ) announced their partnership to prep patients for colonoscopy at the HyGIeaCare® ... Centers in 87th Ave., Miami, FL. , The HyGIeaCare® Prep, cleared ...
(Date:3/24/2017)... ... March 24, 2017 , ... “End Time GPS”: a ... will interrelate. “End Time GPS” is the creation of published author, Wesley Gerboth, ... working on military munitions and space-vehicle projects. Now, at age ninety-one, he shares the ...
(Date:3/23/2017)... & Seattle, WA (PRWEB) , ... March 23, 2017 , ... ... health emergency and now estimates that there could be four million Zika-related cases in ... epidemics to date with numbers of US cases reported per year skyrocketing to an ...
Breaking Medicine News(10 mins):