Medline Industries has initiated a Class I recall, the most serious type, for certain convenience kits containing Huons Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injections. The U.S. Food and Drug Administration (FDA) is aware of Medline's recommendation to customers to correct these kits by removing the affected anesthetic products.
The recall stems from quality issues identified during a recent FDA inspection of Huons Co., Ltd.'s manufacturing facility, which led Huons to recall its Lidocaine and Bupivacaine products. Using these injections with reduced anesthetic effectiveness could result in inadequate pain control, procedural discomfort, or necessitate repeat or delayed treatments.
As of May 20, Medline has reported no serious injuries or deaths related to this issue. The FDA emphasizes that this is a device correction, meaning the products are not being removed from where they are used or sold, but require modification prior to continued use. Customers with questions can contact Medline Industries at 1-866-359-1704 or recalls@medline.com.