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The FDA is aware that Medical Action Industries has issued a letter to affected customers recommending certain epidural kits be corrected prior to continued use by removing components affected by the Huons Co., Ltd. recall.
Medical Action Industries stated that epidural kits may contain sodium chloride ampules manufactured by Huons Co., Ltd. and recalled by Spectra Medical Devices, LLC.
If the sterility of the sodium chloride injection (flush solution) is compromised, patients may be exposed to viable microorganisms, endotoxins, and/or foreign matters generated during manufacturing. This can trigger systemic inflammatory responses, infections, micro-clots, and organ failure. Use in close proximity to the spine may lead to abscess formation, infection of the meninges, and compression injury of the spinal roots leading to paralysis and death.
As of July 23, Medical Action Industries has not reported any serious injuries or deaths associated with this issue.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medical Action Industries at complaints@owens-minor.com.
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