Recall Z-2873-2026
Spectra Medical Devices, Llc · initiated July 6, 2026
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: 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.
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
On July 6, 2026, firm sent letters titled, "Urgent: Medical Device Recall" to customers. Customers were instructed to examine their stock for affected product and discard or return any unused Sodium Chloride Flush ampules from the identified lot numbers. For affected products already in distribution, customers should instruct downstream customers to discard or return unused product. Customers were also instructed to use extra vigilance in detecting and reporting potential patient health concerns that may be related to this product.
Details
- Recall number
- Z-2873-2026
- Initiated
- July 6, 2026
- Posted by FDA
- August 11, 2026
- Product code
- NGT – Saline, Vascular Access Flush
- Quantity
- TBD
- Distribution
- Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Recalling firm
- Spectra Medical Devices, Llc, Wilmington, MA