Tyco Healthcare Group (Covidien) is recalling 4,710 boxes of the syringes - with 00 syringes in each box - that ere sold at Wal-Mart and Sam's Club from Aug. 1, 2008 through Oct. 8, 2008.
The reason for the recall: possible mislabeling and overdose risk.
"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 ypoglycemia, serious health consequences, and even death," states an FDA news release.
The recall only applies to the following products:
Product name: ReliOn Insulin Syringes -- 31 gauge 1 cc (with 100 syringes per box)
Lot number: 813900 (on the back panel of the carton, or on the white paper backing of each syringe's "peel pack"
Product identification number: 38396-0403-02 (on the top panel upper right-hand corner of the syringe box)
The FDA says some syringes labeled for use with U-40 insulin got packaged with syringes for U-100 insulin.
The FDA notes that Tyco Healthcare recalled this lot of syringes in October, and Wal-Mart and Sam's Club stores have posted information about the recall and notified more than 16,500 customers about the recall.
For more information, call 866-780-05436 or visit the ReliOn recall web site for more information. Customers will be provided with a replacement package.
By Miranda Hitti
Reviewed by Louise Chang
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