Recall Z-2873-2026 ยท NGT Saline, Vascular Access Flush
Spectra Medical Devices, Llc
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.
| Date | Aug 11, 2026 (initiated Jul 6, 2026) |
| Status | Open, Classified |
| 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. |
| Root 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 | TBD |
| Distribution | Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA. |
| FDA record | Open on fda.gov |