The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently attached hypodermic needles due to possible mislabeling. If patients use these syringes, they may be receiving an overdose of as much as 2.5 times the intended dose of insulin. An overdose may lead to hypoglycemia, serious health consequences or death.
The recall applies to the following lot number and product information: Lot Number 813900; ReliOn 1 cc, 31-gauge, 100 units for use with U-100 insulin The syringes were sold at Wal-Mart and Sam’s Club stores between August 1, 2008 and October 8, 2008.
These syringes are only sold at Wal-Mart and Sam’s Club stores. Wal-Mart and Sam’s Club asks anyone who purchased this product to return the syringes to their local Wal-Mart store or Sam’s Club pharmacy. Customers will be given replacement syringes.
For more information on this recall, visit http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html.