Drug recall
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule…
FDA recall event 98777 · Class I · Spectra Medical Devices, Llc
Key facts
| Event ID | 98777 |
|---|---|
| Recall numbers | Z-2873-2026 |
| Recalling firm | Spectra Medical Devices, Llc |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 6, 2026 |
| Report date | Aug 19, 2026 |
| City | Wilmington |
| State | MA |
| Country | United States |
| FEI number | 3000204727 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: