ReliOn Syringe Recall
Tyco Healthcare Group/Covidien has recalled 471,000 units of ReliOn sterile, single-use, disposable, hypodermic insulin syringes. A possible labeling error may cause patients to receive an overdose of as much as 2.5 times the intended dose of insulin, which can lead to:
Hypoglycemia (low blood sugar level);
Serious health consequences, and
Death
The recalled ReliOn syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle attached to the tip of the syringe. The syringes are used to administer insulin for the treatment and management of diabetes. To ensure proper dosing, specific insulin formulations must be administered with the appropriate insulin syringe which matches the concentration of insulin used. The concentration of a particular formulation is marked on the vial as U-100 (100 units per milliliter) or U-40 (40 units per milliliter).
All U-100 insulin must be administered using U-100 syringes and all U-40 insulin must be administered using U-40 syringes, or severe dosage errors may result.
According to the FDA, during the packaging process some ReliOn 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. The manufacturer distributed 4,710 boxes in the recalled lot, equaling 471,000 individual syringes. The recalled syringes were distributed by Can-Am Care Corp and sold by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name from August 1, 2008 until October 8, 2008.
Lot numbers:
The lot number are on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”. The product identification number can be found on the top panel upper right hand corner ofthe syringe box.
Our Office is investigating claims involving these syringes. We'd like to help. Please call or email us, and know that all information will be kept confidential. There's no fee unless there is a recovery for you.