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Medline Issues Correction for Convenience Kits Containing B. Braun Bupivacaine Hydrochloride Components
The FDA is aware that Medline has issued a letter to affected customers recommending certain Medline convenience be corrected prior to continued use by removing components affected by the B. Braun Medical, Inc. recall.
Medline is correcting Medline kits containing B. Braun components that include Huons Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co., Ltd. initiated a recall of Bupivacaine HCL in Dextrose Injection, USP.
Risks of using compromised injectables include infection, inflammatory response, and/or reduced anesthetic effectiveness which can lead to emergency conversion to general anesthesia. When used in the neuraxial space, there is a risk of cerebral fluid contamination and meningitis that may progress to encephalitis.
As of April 24, B. Braun has reported 35 serious injuries and no deaths associated with this issue. As of June 19, Medline has not reported any additional serious injuries or deaths associated with this issue.
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact Medline at 866-359-1704 or recalls@medline.com.
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