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.
USBrand 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.
Recalling Firm: Spectra Medical Devices, Llc
Reason for Recall / 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.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Wilmington |
| State | MA |
| Event id | 98777 |
| Address 1 | 299 Ballardvale St |
| Address 2 | Ste 1 |
| 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. |
| Postal code | 01887-1066 |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260706 |
| Center classification date | 20260811 |
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Overview
- Recalling FirmSpectra Medical Devices, Llc
- StatusOngoing
- Risk LevelClass I
- DistributionDistributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
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🚨 SAFETY ALERT: 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. Check if your household is affected: https://therecallfile.com/recalls/brand-name-elevaris-spectra-medical-devices-product-name-sodium-chlori/FDA-Z-2873-2026
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