Medline has issued a Class I recall, the most serious type, for certain convenience kits containing B. Braun components that include Huons Bupivacaine Hydrochloride in Dextrose Injection, USP. The U.S. Food and Drug Administration (FDA) is aware of Medline's letter to affected customers, recommending correction by removing the compromised components from the kits prior to continued use.
The use of these compromised injectables carries significant risks, including infection, inflammatory response, and reduced anesthetic effectiveness, potentially leading to emergency conversion to general anesthesia. When administered in the neuraxial space, there is a risk of cerebral fluid contamination and serious conditions like meningitis, which could progress to encephalitis. B. Braun reported 35 serious injuries and no deaths as of April 24, while Medline has not reported any additional serious injuries or deaths as of June 19.
The FDA emphasized that this action is a "correction" of devices, not a removal from where they are used or sold, but it is still classified as the most serious type of recall due to the potential for serious injury or death if used without correction. Customers with questions should contact Medline at 866-359-1704 or recalls@medline.com.