B. Braun Medical, Inc. has issued a recall for spinal anesthesia kits containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, following a prior recall initiated by Huons Co., Ltd. on April 2 for the injectable itself. The U.S. Food and Drug Administration (FDA) is aware of B. Braun's action, which recommends removing affected kits from use or sale.
Using compromised injectables carries risks including infection, inflammatory response, or reduced anesthetic effectiveness. When administered in the neuraxial space, there is a heightened risk of cerebral fluid contamination, meningitis that could progress to encephalitis, and the potential need for emergency conversion to general anesthesia. As of April 24, B. Braun has reported 35 serious injuries associated with this issue, with no reported deaths.
The FDA has classified this as the most serious type of recall, indicating that continued use of the device may cause serious injury or death. Customers with questions or concerns regarding adverse reactions or quality problems should contact B. Braun Medical, Inc. at recalls@bbraunusa.com or by phone at (844) 903-6417.