Recall Z-2873-2026— Spectra Medical Devices, Llc
Class I · Ongoing
Class I FDA medical device recall by Spectra Medical Devices, Llc, initiated 2026-07-06. It names 2 FDA 510(k) clearances: K103740, K082689. 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.. 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..
- Recalling firm
- Spectra Medical Devices, Llc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-07-06
- Firm location
- Wilmington, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K103740 — SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
- K082689 — STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.