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: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)... June 24, 2016 Research and Markets ... for Companion Diagnostic Tests" report to their offering. ... Companion Diagnostics The World Market for Companion ... medicine diagnostics. Market analysis in the report includes the following: ... (In Vitro Diagnostic Kits) by Region (N. America, EU, ROW), ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American Institutes ... Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , ... advance care planning, healthcare costs and patient and family engagement. , AIR researchers ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library ... City Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ... for fumigation is not a common occurrence, but a necessary one in the event that ...
(Date:6/25/2016)... ... 2016 , ... First Choice Emergency Room , the largest network of ... Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased to ... said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as ... City area —Johnson is one of the first doctors to perform the treatment. ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of ... too high can result in disappointment, perhaps even self-loathing. However, those who set the ... Research from PsychTests.com reveals that behind the tendency to set low expectations ...
Breaking Medicine News(10 mins):