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The U.S. Food and Drug Administration (FDA) is aware that Medline has issued a letter to affected customers recommending certain convenience kits be corrected prior to continued use by removing included Bupivacaine Hydrochloride in Dextrose Injections. Huons Co., Ltd. initiated a recall of Bupivacaine HCL in Dextrose Injection, USP, following a recent FDA inspection of its manufacturing facility that identified quality issues. Risks of using compromised injectables include infection, inflammatory response and/or reduced anesthetic effectiveness. When used in the neuraxial space, there is a risk of cerebral fluid contamination and meningitis that may progress to encephalitis.
As of April 10, Medline has reported no 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 adverse reactions, quality problems, or questions about this recall should contact Medline Industries at 1-866-359-1704, or via email at recalls@medline.com.
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