Elevaris Sodium Chloride Injection 10mL Ampule
Spectra Medical Devices recalls Elevaris Sodium Chloride Injection 10mL Ampules over sterility concerns.
Stop using the recalled Sodium Chloride Injection 10mL Ampules immediately. Contact Spectra Medical Devices for instructions on returning the product and obtaining a replacement or refund.
Why it was recalled
Spectra Medical Devices is recalling Elevaris Sodium Chloride Injection, 0.9%, USP 10mL Ampules (Model/Catalog Number: AMPUL10MLK) due to sterility assurance issues at the manufacturing firm, Huons. Compromised sterility may expose patients to microorganisms, endotoxins, or foreign matter, potentially causing inflammatory responses, infections, micro-clots, and organ failure.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Elevaris/Spectra Medical Devices Sodium Chloride Injection, 0.9%, USP 10mL Ampule
- Model/Catalog number
- AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices
Where it was sold
Distributed in California, Florida, North Carolina, Oklahoma, Texas, and Virginia.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Sterility Failure recalls
Other recent recalls from Spectra Medical Devices, Llc
Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification