Class 1 Recall: Tyco Healthcare Group LP (Covidien), ReliOn Insulin Syringes, 1cc, 31-Gauge

ReliOn Insulin Syringes, 1cc, 31-gauge, 100 units for use with U-100 insulin, Lot Number 813900, Product Code 38396-0403-02

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are subject to this recall.

An insulin injection is used to control blood sugar in people who have type 1 or type 2 diabetes and who cannot control their diabetes with oral medicines.

Some packages were mislabeled. The syringes labeled for use with U-40 unit insulin were mixed with syringes labeled for use with U-100 insulin. 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 hypoglycemia (abnormally low level of blood sugar), serious health consequences, and even death.

Tyco Healthcare Group, LP (Covidien) notified Can-Am Care, Corporation (the distributor of these syringes) by letter sent by e-mail and by Federal Express on October 9, 2008. The letter requests that they immediately:

• inventory, quarantine and return any remaining stock they may have of the product, and
• notify their customers.

Can-Am Care, whose name appears on the product label, has also posted a notice on their website.

Wal-Mart and Sam’s Clubs conducted consumer mailings on Oct. 14, 2008, posted the recall announcement in their stores, and on Wal-Mart’s website, and are posting placards (posters) in their stores.

Wal-Mart and Sam’s Club are asking their customers to return ReliOn 1cc, 31-gauge syringes 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 for a replacement product.

For additional information, see FDA’s Press Release at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online:www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178