Covidien Ltd is recalling nearly half a million single-use syringes that could pose a serious risk to diabetics.
During the packaging process, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin.
The ReliOn syringes were mislabeled during the packaging process and could lead to patients receiving an insulin overdose of as much as 2.5 times the intended dose which could in turn lead to low blood sugar levels and serious health consequences, including death.
The syringes were sold at Wal-Mart stores and Sam’s Clubs from August 1 until October 8, the FDA said.
The FDA said the manufacturer has received one adverse report related to a syringe from the lot numbered 813900.
Consumers and health care professionals who suspect they have the recalled product may contact Covidien at 866-780-5436 or www.relion.com/recall for more information.