Device Class I · high risk Ongoing Aug 19, 2026

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.

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.

Recalling firm	Spectra Medical Devices, Llc
Reason	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.
Risk class	Class I (Class I · high risk)
Status	Ongoing
Report date	Aug 19, 2026
Initiated	Jul 6, 2026
Region	MA, United States
Distribution	Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
Quantity	TBD
Code/Lot	Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB50…
Type	Voluntary: Firm initiated
Recall number	Z-2873-2026

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