Diabetic Dog & Cat owners check your insulin syringes to be sure you do not have the Reli ON brand! The FDA issued a nationwide recall of insulin syringes used for diabetic pets and people. The syringes are made by Tyco and are labeled for a single use. The syringes have permanently affixed hypodermic needles on them but they are mislabeled. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to low blood sugar, which called hypoglycemia, serious health consequences, and even death.
The following lot number and product information have been recalled:
- Lot Number 813900
- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin
- ReliOn syringes from this lot number, labeled as 100 units for use with U-100 insulin are the only item being recalled.
Distributors include Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam’s Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam’s Club pharmacy. Customers will be provided with replacement product. Pet owners and health care professionals need to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900.
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. ReliOn Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle attached to the tip of the syringe.
The problem occurred during the packaging process for this lot; some 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 has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam’s Clubs from Aug. 1, 2008, until Oct. 8, 2008.
Tyco Healthcare Group LP (Covidien) voluntarily recalled this lot of syringes on Oct. 9, 2008, asking that any units of the affected product be removed from inventory and placed in quarantine. Wal-Mart posted the recall announcement in Wal-Mart stores and Sam’s Clubs, as well as on its Web site, and sent letters to more than 16,500 customers notifying them of the recall.
At this point, one adverse report related to a syringe from this product lot has been reported.
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, by regular mail, fax or phone.
Relevant Links include: www.fda.gov/MedWatch/report.htm For Regular Mail: use postage-paid FDA form 3500, which is available online at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088
