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.
FDA Recall Z-2873-2026 · Posted 2026-08-11
Recalling FirmSpectra Medical Devices, Llc
Recall StatusOpen, Classified
Product CodeNGT
Date Initiated2026-07-06
Product QuantityTBD
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.