Possible Overdosage Prompts ReliOn 31-Gauge Insulin Syringes Recall
FDA on Wednesday announced the recall of nearly a half million ReliOn 31-Gauge Insulin Syringes that could result in serious and potentially deadly insulin overdosage.
The recall of ReliOn 31-Gauge Insulin Syringes involves lot 813,900 units of ReliOn 31-gauge, 1-cc single-use insulin syringes produced by Covidien (formerly Tyco Healthcare) and sold at Sam's Club and Wal-Mart stores. According to the FDA group that regulates medical devices, Can-Am Care Corporation distributed the syringes and it is that company's name that appears on the label.
FDA stated that the recalled syringes designed for use with 40-unit/mL, or U-40, insulin were inadvertently mixed with syringes intended to deliver 100-unit/mL, or U-100, insulin, and were subsequently packaged for sale as U-100 syringes.
Patients who use a U-40 syringe with U-100 insulin can inadvertently receive more than twice the intended dosage of the drug and are at risk for serious or possibly fatal hypoglycemia. This risk has caused ReliOn 31-Gauge Insulin Syringes Recall.
According to FDA, Covidien has received one report of an adverse event associated with the use of the recalled lot of syringes.
The recalled ReliOn 31-Gauge Insulin Syringes were packaged both individually and in boxes of 100 and shipped to stores between August 1 and October 8 of this year. According to FDA, Covidien began the recall October 9, and the company has sent letters about the recall to thousands of customers.
FDA stated that patients and health care providers should carefully check the packaging of their insulin syringes to determine whether they are from the affected lot.
Patients who have purchased the recalled ReliOn 31-Gauge Insulin Syringes should call 866-780-5436 for product replacement instructions.
Relion.com has issued a letter to customers in regard to ReliOn 31-Gauge Insulin Syringes Recall.
URGENT: Medical Device Recall – ReliOn 31 gauge 1 cc syringes with lot number 813900.
Tyco Healthcare Group LP (Covidien) is voluntarily recalling:
A single lot of ReliOn 31 gauge 1 cc syringes (lot #813900, shipped between August 1st, 2008 through October 8th, 2008)
The U.S. Food and Drug Administration has been informed of this action.
The affected lot could have syringes mislabeled with inaccurate dosage increments, which could result in patients not receiving the correct dosage of their medication.
Product Subject to Recall:
Product Name Product Identification Number Lot Number
ReliOn Insulin Syringes -
31 gauge 1cc 38396-0403-02 813900
Where you can find the lot number:
The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.
Where you can find the product identification number:
The product identification number can be found on the top panel upper right hand corner of the syringe box.
What you should do:
If you have ReliOn syringes with this lot number (lot #813900) please call 866-780-5436 for product replacement instructions. You may also visit www.relion.com/recall for instructions or simply bring back to the pharmacy for a replacement box.
What will happen:
You will be mailed a complimentary box of replacement ReliOn syringes along with a pre-paid U.S. Mail return label & return shipper. The return label should be used to send the recalled syringes in the return carton back to Can-Am for investigation.
A message to our consumers:
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.