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Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules
The FDA is aware that Elevaris Medical Devices, doing business as Spectra Medical Devices, has issued a letter to affected customers recommending certain Sodium Chloride Flush products affected by the Huons Co., Ltd. recall be removed from where they are used or sold.
Spectra Medical Devices is removing Sodium Chloride Flush products that were manufactured by Huons Co., Ltd. (Huons). Huons initiated a recall of Sodium Chloride Injection 0.9%, USP following an FDA inspection of its manufacturing facility, which identified quality issues.
If the products’ sterility is compromised, viable microorganisms, endotoxins, and/or foreign matters that are generated during manufacturing may be exposed to patients. They can trigger systemic inflammatory responses, infections, micro-clots, and organ failure, especially in high-risk populations.
As of July 6, Spectra Medical Devices has not reported any serious injuries or deaths associated with this issue.
This recall involves removing certain devices 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.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Spectra Medical Devices at RecallCoordinator@elevarismedical.com.
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