Nationwide Recall of Mislabeled ReliOn Insulin Syringes
Posted by PKSD Law Firm on Nov 07, 2008 in Defective Medical Devices
According to the U.S. Food and Drug Administration, 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
Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.
Click here for the entire FDA news release.