Z-2873-2026Class I

Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule...

Name: Z-2873-2026 Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule...
Creator: Spectra Medical Devices, Llc
Published: 2026-07-06
License: https://open.fda.gov/license/

Spectra Medical Devices, LLC / initiated 2026-07-06 / Open, Classified / root cause: manufacturing process

FDA source

Spectra Medical Devices, Llc began a recall of Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride... on 2026-07-06. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2873-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-07-06
Posted: 2026-08-11
Recalling firm: Spectra Medical Devices, LLC
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.
Product code: NGT Saline, Vascular Access Flush
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.
Root cause tag: manufacturing process
FDA 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 in commerce: TBD
Distribution: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2873-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2873-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-11

Product code NGT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)