Medical Action Industries has issued an alert regarding certain epidural kits that may contain recalled sodium chloride ampules, posing significant health risks to patients. The U.S. Food and Drug Administration (FDA) is aware of the issue, which stems from components manufactured by Huons Co., Ltd. and previously recalled by Spectra Medical Devices, LLC.
The compromised sterility of the sodium chloride injection, used as a flush solution, could expose patients to microorganisms, endotoxins, or foreign matter. This exposure may lead to severe outcomes including systemic inflammatory responses, infections, micro-clots, and organ failure. If used near the spine, it could result in abscess formation, meningeal infection, spinal root compression injury, potentially causing paralysis and death.
As of July 23, Medical Action Industries has not reported any serious injuries or deaths related to this issue. Customers with questions or concerns are advised to contact Medical Action Industries at complaints@owens-minor.com.