Medical Device Recall: 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 ind
Spectra Medical Devices, Llc · July 6, 2026
Reason for Recall
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
Product Description
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.
Distribution
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
States Affected
CA, FL, IN, NC, OK, TX, VA
Quantity Affected
TBD
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2873-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.