Spectra Medical Devices Sodium Chloride Injection Recall (Unknown Month Year)
Announced 2026-08-19 · FDA
The recall involves Spectra Medical Devices’ brand Sodium Chloride Injection, 0.9%, USP 10mL Ampule (AMPUL10MLK) distributed to medical device kit packers in CA, FL, NC, OK, TX, and VA. The reason cites issues with product quality and sterility assurance by Huons; if sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter, potentially causing inflammatory responses, infections, micro-clots, and organ failure. The recall includes lots AB3005-AB3010, AB4001-AB4006, AB5001-AB5008 and product codes 1510-1 and 1510-2.
| Brand | Spectra Medical Devices, Llc |
|---|---|
| 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. |
| Severity | critical |
| Units affected | TBD |
| Distribution | Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA. |
| Agency | FDA |
| Recall / campaign no. | 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, AB5004, AB5005,AB5006, AB5007, AB5008 No individual UDI, as this product is used only within convenience kits. |
WHAT YOU SHOULD DO
- Do not use any affected ampules or kits with the listed product codes or lots AB3005-AB3010, AB4001-AB4006, AB5001-AB5008 (1510-1/1510-2).
- Coordinate with your facility’s safety officer or Spectra Medical Devices for recall return, replacement, or disposal instructions.
- If exposure or adverse symptoms are suspected, seek medical evaluation and report the incident to the appropriate authorities.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.