The kidney community uses a variety of products and resources to ensure the health and safety of patients and healthcare professionals. The United States Food and Drug Administration (FDA) issues alerts and notifications when these products and resources are unsafe or being recalled.
As directed by CMS, the KCER Coalition issues notices on FDA recalls via email and this website for the kidney community. To join the email list, please email sburris@nw7.esrd.net.
November 6, 2008
ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)
Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. 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”.
