BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

FDA and Excelsior Medical Corporation Recall Prefilled Saline Flush Syringes; FDA Classified this Action as a Class I Recall


10/19/2010 7:46:16 AM

FOR IMMEDIATE RELEASE - October 14, 2010 - NEPTUNE, N.J. -- Excelsior Medical Corporation issued the following update regarding their previously disclosed nationwide recall of Excelsior Disposable 5ml fill in 6 cc Prefilled Saline Flush Syringe W/Normal Saline (0.9 % Sodium Chloride). 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 or exposure to a violative product will cause serious adverse health consequences or death.

The Excelsior Disposable 5ml fill in 6 cc prefilled saline flush syringes are intended for the flushing of venous access devices and IV tubing.

On September 2, 2010, the company sent an urgent Medical Device Recall Notification to customers of its Excelsior Disposable 5ml fill in 6 cc prefilled saline flush syringe product stating that routine internal testing conducted on this product found that some of these syringes may leak and lose sterility. This recall pertains only to the 5ml fill in 6 cc pre-filled saline flush syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. The product code number can be found in the barcode on each syringe as well as on the carton label. Exposure to syringes with a leaking and sterility issue could result in systemic infection, which may lead to serious injury and/or death. All product affected by this recall had passed all release testing including sterility testing. The company decided to undertake this recall as a precautionary measure.

No other Excelsior Medical pre-filled saline syringe product codes are affected by this recall.

Instructions to Customers

Consumers who have 5ml fill in 6 cc saline pre-filled syringes, manufactured by Excelsior Medical, should immediately discontinue using these syringes and return them to the point of purchase. Excelsior Medical Corporation has notified its distributors and customers by letter and is arranging for return/destruction and reimbursement of any products that are returned as a result of this recall. For more information, consumers may contact the company at 1-800-487-4276, by fax at 1-866-688-3185 or e-mail at recall10@excelsiormedical.com.

The affected products are distributed to hospitals and home health care agencies by Excelsior Medical's network of med-surge, pharmacy and independent medical distributors. This product is available by prescription only and is not sold over the counter. This recall covers certain products (as outlined above) distributed within the United States, Canada and Brazil.

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/medwatch9.

About Excelsior Medical Corporation

Excelsior Medical Corp. is a privately held company with a primary focus on innovative catheter maintenance products that may reduce infection, medication errors and healthcare costs. Excelsior makes SwabCap for disinfection and protection of IV luer access valves. Formed in 1989, Excelsior is one of the world's leading manufacturers of pre-filled catheter flush syringes. The company manufactures, markets and sells pre-filled saline flush syringes, pre-filled heparin flush and lock syringes, syringe pump systems and valve disinfection caps. For more information, call toll-free 800-487-4276 or access www.excelsiormedical.com10.


Read at BioSpace.com
Read at News Release

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES