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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 the components affected by the Huons Co., Ltd. recall.
Medline is issuing a recall for specific Medline Kits containing ICU Medical, Inc. pain management kits with 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. When used in the neuraxial space, there is a risk of cerebral fluid contamination and meningitis that may progress to encephalitis and emergency conversion to general anesthesia.
As of June 8, Medline, Medline has not reported any 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 Industries at 1-866-359-1704, or via email at recalls@medline.com.
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