Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0
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.
- Agency
- FDA Device
- Recall date
- Jul 6, 2026
- Status
- Ongoing
- Company
- Spectra Medical Devices, Llc
1. What product was recalled?
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0
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.
Quantity: TBD
Code or lot text: 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.
- LOT
- AB3006
- LOT
- AB3007
- LOT
- AB3008
- LOT
- AB3009
- LOT
- AB3010
- LOT
- AB4001
- LOT
- AB4002
- LOT
- AB4003
- LOT
- AB4004
- LOT
- AB4005 AB4006
- LOT
- AB5001
- LOT
- AB5002
- LOT
- AB5003
- LOT
- AB5004
- LOT
- AB5005
- LOT
- AB5006
- LOT
- AB5007
- LOT
- AB5008 No individual UDI
- LOT
- Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005
- LOT
- as this product is used only within convenience kits.
- RECALL-NUMBER
- Z-2873-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
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.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
California, Florida, North Carolina, Oklahoma, Texas, Virginia
View source evidence for state distribution
- California: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Florida: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- North Carolina: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Oklahoma: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Texas: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Virginia: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.