Becton Dickinson Issues Correction for Spinal Trays with Bupivacaine Ampules

Becton Dickinson & Company has issued a correction for its BD Spinal Trays, advising customers to remove bupivacaine ampules due to quality concerns. The U.S. Food and Drug Administration (FDA) is aware of this action, which stems from issues identified during a recent FDA inspection and reports of drug ineffectiveness.

The bupivacaine ampules, manufactured by Huons Co., Ltd., were found to have quality problems. The FDA has classified this as the most serious type of recall, indicating that continued use without correction could lead to serious injury or death. Risks associated with compromised injectables include localized infection, inflammatory response, or reduced anesthetic effectiveness.

As of April 27, Becton Dickinson has reported no serious injuries or deaths linked to this issue. Customers with questions or adverse reactions are advised to contact Becton Dickinson & Company directly.