Tyco Healthcare Group LP (Covidien), has recalled one lot of ReliOn sterile, single-use hypodermic syringes sold at Wal-Mart and Sam's Clubs stores. This investigation focuses on Tyco Healthcare's (Covidien) conduct in allowing these tainted ReliOn single dose syringes on the market.
The syringes were recalled because of the potential that they are mislabeled and potentially contain more than twice the intended dose of insulin. Patients are advised of the serious health risks associated with receiving the high dose including, hypoglycemia and death. One incident has been reported, according to the Food and Drug Administration. "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," according to an FDA news release. The recall only applies to the following products: -Product name: ReliOn Insulin Syringes - 31 gauge 1 cc (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, and Wal-Mart and Sam's Club stores have posted information about the recall and notified more than 16,500 customers about the recall.
Name (Stock Symbol)
Tyco Healthcare Group LP
Tyco Healthcare Group LP manufactures and sells medical devices. It is a wholly owned subsidiary of Covidien.
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