Spectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns

Plain-English summary

Spectra Medical Devices, LLC is recalling Sodium Chloride Injection, 0.9%, USP 10mL Ampules (Model/Catalog Number: AMPUL10MLK) under the brand name Elevaris. The product is used as a sodium chloride flush for IV tubing systems and indwelling intravascular access devices. The recall involves specific lots: AB3005 through AB3010, AB4001 through AB4006, and AB5001 through AB5008. These products were distributed in the United States to medical device kit packers in California, Florida, North Carolina, Oklahoma, Texas, and Virginia.

The recall was initiated because the manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the sterility of the product is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. Such exposure may trigger inflammatory responses, infections, micro-clots, and organ failure.

Healthcare facilities and medical device kit packers should stop using the affected lots immediately. Consumers and patients should contact their healthcare provider if they have received or used these specific ampules to determine if further medical evaluation is necessary.

The recalled product

Product

Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.

Manufacturer

Spectra Medical Devices, Llc

Category

Medical Device — IV Flush / Injection

Hazard

• infection
• sterility-compromise
• foreign-matter

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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