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Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine Ampules
The FDA is aware that Argon Medical has issued a letter to affected customers recommending certain convenience kits be corrected prior to continued use by removing components affected by the Huons Co., Ltd. recall.
Argon Medical is issuing a recall for specific Argon Medical kits containing Spectra Medical Device, Inc. pain management kits with Huons lidocaine HCL Injection.
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 1, Argon Medical has reported 2 serious injuries and no 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 Argon Medical at quality.regulatory@argonmedical.com.
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