Class I — Spectra Medical Devices, Llc
| Recalling firm | SPECTRA MEDICAL DEVICES, LLC |
|---|---|
| Registered facility | SPECTRA MEDICAL DEVICES, LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| 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. |
| 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. |
| Quantity | TBD |
| Distribution | Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA. |
| Initiated | 2026-07-06 |
| Classified | 2026-08-11 |
| Recall number | Z-2873-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Spectra Medical Devices, Llc (Z-2873-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98777/
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