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November 21, 2008

Nationwide Recall of Mislabeled ReliOn Insulin Syringes

The U.S. Food and Drug Administration has been informed of a recall of on lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles offered by Tyco Healthcare Group LP (Covidien) due to possible mislabeling. It is believed that if patients use the needles they could receive as much as 2.5 times the intended dose which could lead to hypoglycemia, serious health consequences and even death. The recall applies to Lot Number 813900, ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin. The syringes are distributed by Can-Am Care Corp and sold only by Walmart and Sam’s Club stores under the Reli-on name. The mistake was made during the packaging process. The recall includes 4,710 boxes which has a total of 471,000 bad syringes. The manufacturer has received one adverse report related to a syri nge from this product lot.

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