FDA notified healthcare professionals and patients today that 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 the 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 and 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, according to the FDA.
The agency said that the syringes are distributed by Can-Am Care and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart has requested that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from lot number 813900 to their local Wal-Mart store or Sam's Club pharmacy. They said that customers will be provided with replacement products.
During the packaging process for this lot, the agency said that some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin. Covidien, formerly Tyco Healthcare Group, has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam's Clubs from Aug. 1 through Oct. 8.
The FDA is urging patients and healthcare professionals to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from lot number 813900.