Class 1 Device Recall Elevaris/Spectra Medical Devices Sodium Chloride Flush

• Date Initiated by Firm: July 06, 2026
• Date Posted: August 11, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2873-2026
• Recall Event ID: 98777
• 510(K)Number: K082689 K103740
• Product Classification: Saline, vascular access flush - Product Code NGT
• 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.
• 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.
• FEI Number: 3000204727
• Recalling Firm/ Manufacturer: Spectra Medical Devices, Llc; 299 Ballardvale St ; Ste 1; Wilmington MA 01887-1066
• For Additional Information Contact: Kathy Dassler; US-978-6570889
• Manufacturer 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: 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.
• Quantity in Commerce: TBD
• Distribution: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NGT