Spectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
Spectra Medical Devices is recalling Sodium Chloride Injection ampules because manufacturing issues may have compromised sterility, posing a risk of infection or inflammation to patients.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that compromised sterility may trigger infections, micro-clots, and organ failure, which aligns with the rubric criterion for 'significant injury' reports or risks, warranting a Severe (4) classification.
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
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- AB3006
- AB3007
- AB3008
- AB3009
- AB3010
- AB4001
- AB4002
- AB4003
- AB4004
- AB4005 AB4006
- AB5001
- AB5002
- AB5003
- AB5004
- AB5005
- AB5006
- AB5007
- AB5008 No individual UDI
- as this product is used only within convenience kits.
Distribution
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