ReliOn Syringes Sold At Walmart, Sam’s Club Recalled

HARTFORD — The Department of Consumer Protection is urging consumers who treat their diabetes with insulin to check their syringes in light of a product recall announced by the US Food and Drug Administration (FDA).

Tyco Healthcare Group LP (Covidien) is recalling Lot Number 813900 ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which could lead to hypoglycemia, serious health consequences, and even death.

The recall applies to the following lot number and product information:

*Lot Number 813900

*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. 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.”

Sold only by Walmart at Walmart stores and Sam’s Clubs under the ReliOn name, these syringes are distributed by Can-Am Care Corp.

“At this time, we don’t have information as to specifically in which state or states these were sold; we only know that Walmart and Sam’s Club carried them,” Consumer Protection Commissioner Jerry Farrell, Jr, said. “I strongly urge patients who buy their syringes at Sam’s Club or Walmart to check their cabinets carefully. Any syringes that are subject to this recall should be returned to a local Walmart store or Sam’s Club pharmacy for a replacement product.” Consumers and health care professionals who suspect they have the recalled product may also contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

The syringes sold at Walmart stores and Sam’s Clubs from August 1, 2008, until October 8, 2008.

The manufacturer has received one adverse report related to a syringe from this product lot. Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, www.fda.gov/MedWatch/report.htm; by regular mail; fax, 800-FDA-0178; or phone, 800-FDA-1088