Device recall
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.
- Recall number
- Z-2873-2026
- Event id
- 98777
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- Spectra Medical Devices, Llc
- Report date
- Aug 19, 2026
- Initiated
- Jul 6, 2026
- Center classification date
- Aug 11, 2026
- 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.
- Quantity
- TBD
- Code info
- 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.
- Distribution
- Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Wilmington, MA, United States