Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalo
FDA device recall Z-2873-2026 · posted 2026-08-11 · Open, Classified
Recall details
- Recalling firm
- Spectra Medical Devices, Llc
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- NGT
- Quantity affected
- TBD
- Distribution
- Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Date initiated
- 2026-07-06
- Date posted
- 2026-08-11
- Location
- Wilmington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE (K103740) | Spectra Medical Devices, Inc. | 2011-07-29 |
| STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE (K082689) | Spectra Medical Devices, Inc. | 2009-03-20 |