Urgent Voluntary Recall of ReliOn Insulin Syringes

An urgent voluntary Medical Device Recall for a single lot of ReliOn 31 gauge 1 cc syringes has been announced. The U.S. Food and Drug Administration (FDA) has also been informed of the recall and reports that the manufacturer has already received one adverse report related to a defective syringe.

Tyco Healthcare Group LP (Covidien) has issued the voluntarily recall for lot number 813900 due to its possible content of defective syringes. The lot was shipped between August 1st, 2008 and October 8th, 2008. The lot contained 4,710 boxes of 100 insulin syringes. The product identification number of the syringes is 38396-0403-02.

The syringes were sold at Wal-Mart and Sam’s Club. Any one of these syringes could be mislabeled with inaccurate dosage increments. The mislabeling could result in diabetic patients receiving an incorrect dosage of medication, which may lead to serious health issues.

Recall announcements have been posted in both Wal-Mart stores and Sam’s Clubs as well as on the Wal-Mart website. In addition, the company has sent out letters to over 16,500 customers informing them of the recall.

According to a statement released by the FDA, The use of these medical devices “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.” In addition, the agency reports that some syringes labeled for use with U-40 insulin were packaged with syringes for U-100 insulin.

The lot number is located on the back panel of the 100-count syringe carton as well as on the white paper backing of each individual syringe “peel-pack”. The product identification number is located on the top panel in the upper right hand corner of the syringe box.

If you have any ReliOn syringes marked with the affected lot number (lot #813900) please take one of the following actions:

• Call ReliOn at 866-780-5436 to receive product replacement instructions.
• Visit www.relion.com/recall for replacement instructions.
• Return the syringes to the pharmacy where purchased for replacements.

If you use the telephone or online replacement options, you will be mailed a free box of replacement ReliOn syringes plus a pre-paid U.S. Mail return label and shipping container. Use the return label to mail the recalled syringes in the return carton provided to Can-Am for inspection and investigation.

Consumers may also report any experiences of side effects resulting from the use these syringes to the FDA’s MedWatch program by accessing the MedWatch Online Voluntary Reporting Form.

ReliOn is taking the issue very seriously and has posted a message on their website recall page stating, “Product safety and quality continue to be our number one priority. We apologize for any confusion or inconvenience this issue may cause you. We value your continued support. If you have any additional questions, please contact us directly at 1-866-780-5436."