Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Cat
Summary
The FDA issued a Class I for Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Inje by Spectra Medical Devices, Llc. Reason: Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients m.
Details
Source
Device Recall
External ID
Z-2873-2026
Action Date
2026-08-19
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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.
Quantity Affected: TBD
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.
Distribution
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-06
Company
Wilmington, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 160 device recalls issued in the same week, part of 376 device-related FDA actions this month.
Spectra Medical Devices, Llc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spectra Medical Devices, Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spectra Medical Devices, Llc have FDA actions?
Spectra Medical Devices, Llc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2873-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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