Z-2873-2026 Class I Ongoing
FDA device recall Z-2873-2026 was initiated by Spectra Medical Devices, Llc on July 6, 2026 and is designated Class I. 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 fo… The recall status is ongoing. Affected quantity: TBD.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2026
- Initiation Date
- July 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- TBD
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.
Distribution Pattern
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
Code Information
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.