FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes

FOR IMMEDIATE RELEASE November 5, 2008

Media Inquiries: Siobhan DeLancey, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

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

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