The U.S. Food and Drug Administration (FDA), is notifying doctors and patients that Tyco Healthcare Group LP (Covidien) is recalling 471,000 single-use disposable, insulin syringes that could pose a serious health risk to diabetic users.
The FDA warns use of the mislabeled ReliOn syringes could lead to patients receiving an overdose of as much as 2.5 times the recommended dose, which could lead to hypoglycemia and other serious adverse health effects (side effect), including death.
Hypoglycemia, also known as "low blood sugar," is commonly associated with diabetes; however, anyone can experience episodes of low blood sugar. If untreated, hypoglycemia can become a medical emergency for someone suffering from diabetes.
During the packing process, a lot of syringes labeled for use with U-40 insulin became mixed with syringes labeled for use with U-100 insulin.
The recall applies to the following lot number and product information:
-- Lot Number 813900
-- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin
Tyco HealthCare Group, the manufacturer of the ReliOn syringes, issued a voluntary recall on October 9, 2008 which asked retailers to remove the products from shelves and place them in quarantine.
Wal-Mart and Sam Club stores sold the syringes from August 1, 2008 until October 8, 2008. Consumers who purchased syringes from either of these stores may return the product to any store location and will be provided with a replacement product.
To date, one adverse event in connection with the recalled lot has been reported to the company, according to the FDA.
Consumers who believe they have the recalled product can contact Covidien directly at (866) 780-5436 or visit their website for product replacement instructions.
Consumers may also report any side effects that result from using the recalled syringes to the FDA’s MedWatch program. FDA MedWatch Contact Information: Phone: (800) FDA-1088 / Fax: (800) FDA-0178. #