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The 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 Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injections.
Medline Industries is removing Huons Lidocaine Hydrochloride Injection and Bupivacaine Hydrochloride in Dextrose Injection from certain convenience kits. Huons Co., Ltd. initiated a recall of Lidocaine Hydrochloride Injection and Bupivacaine HCL in Dextrose Injection following a recent FDA inspection of its manufacturing facility, which identified quality issues. Use of lidocaine and bupivacaine product with reduced anesthetic effectiveness may result in ineffective pain control, procedural discomfort, or repeat or delayed treatment.
As of May 20, Medline has reported no serious injuries and 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 Industries at 1-866-359-1704, or via email at recalls@medline.com.
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