FDA Reports Needle Recall of Mislabeled ReliOn Insulin Syringes November 6, 2008
The FDA is notifying health care professionals and patients that Tyco Healthcare Group LP
(Covidien) is recalling one lot of ReliON sterile, single-use, disposable, hypodermic syringes with permanent attached hypodermic needles due to a possible mislabeling. The use of this syringe may lead to patients receiving an overdose of insulin as much as 2.5 times the intended dose, which may lead to hypoglycemia, severe health consequences and even death.
The recall is of Lot # 813900 of 1cc 31g 100U for use with U-100 insulin. These were sold at Wal-Mart and Sam's Club stores. Consumers can contact Covidien at 866-780-5436 or www.relion.com/recall for more information.