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November 2008
Company:
Tyco Healthcare Group LP (Covidien)
Product:
ReliOn Insulin Syringes
The U.S. Food and Drug Administration notified health care professionals and patients that Tyco Healthcare Group LP (Covidien) recalled 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 Lot Number 813900, ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin. Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall. These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.
 
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