Carefully check your Insulin syringes

The U.S. Food and Drug Administration (FDA) have announced an urgent Medical Device Recall. The announcement says the subject of the recall is a single production lot of ReliOn 31 gauge 1cc single-use insulin syringes.

The recall was purely voluntary on the part of the syringe manufacturer, Covidien (formerly Tyco Healthcare Group LP), due to a possible inclusion of defective syringes. Shipments of this lot to stores occurred between August 1 and October 8, 2008. The single lot involved in the recall carries the following relevant information:

Lot number    :  813900
Product identification number : 38396-0403-02

The production lot involves a total of 4,710 boxes with each box containing 100 insulin syringes. These were sold at Wal-Mart and Sam’s Club.

The defect in the syringes is a possible mislabeling of the cylinder with inaccurate dosage increments. This mislabeling could lead to an incorrect dosage — an overdose — of insulin medication administered to diabetic patients and which could have serious consequences on health.

Some of the syringes were labeled for use with U-40 insulin (40 units per milligram), but they were inadvertently packed along with syringes intended to deliver 100 units of insulin per milligram) and could consequently be sold as U-100 insulin syringes.

The FDA statement on the recall says that use of the U-40 syringes to deliver U-100 insulin could cause patients to receive “as much as 2.5 times the intended dose.” The overdose could trigger a sudden drop in the amount of blood sugar, leading to hypoglycemia, serious health issues, and possibly death.

The FDA stated in its announcement that there has been one report of an adverse event linked to the use of the recalled syringes.

Covidien actually started its voluntary recall on October 9, a day after the last shipment of the lot to stores. The company has sent letters to thousands of customers, including stores, hospitals and clinics, to relay specific information about the mislabeled syringes.

All health care providers as well as individual diabetic patients are advised by the FDA to carefully check the insulin syringes and the packaging, to determine if these belong to the recalled lot.

The lot number can be found on the back panel of the syringe carton (containing 100 syringes), but on the individual syringe, it is located on the white paper backing of the “peel-packing.” The product identification number can found on the top panel in the upper right hand corner of the syringe box.

Consumers can call ReliOn (866-780-5436) to receive product replacement instructions.