FDA and Excelsior Medical Corporation Recall Prefilled Saline Flush Syringes; FDA Classified this Action as a Class I Recall
Published: Oct 19, 2010
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 firstname.lastname@example.org. 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.