Spectra Medical Devices recalls 10mL Sodium Chloride Injection ampules due to potential contamination. If sterility is compromised, patients may develop infections, micro-clots, or organ failure. Affected lots include AB3005-AB5008.
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.
Spectra Medical Devices is recalling 10mL Sodium Chloride Injection ampules that may be contaminated. If the solution is not sterile, patients could get infections, blood clots, or organ damage. This is a serious risk for medical users.
The injection solution may contain microorganisms, endotoxins, or foreign particles due to manufacturing issues. This can cause infections, inflammation, blood clots, or organ failure in patients receiving the treatment.
Healthcare professionals and patients using the recalled sodium chloride injection for IV treatments. Those with compromised sterility are at highest risk.
Check for ampules labeled 'Sodium Chloride Injection, 0.9%, USP 10mL' with lot codes AB3005 through AB5008. The product is sold in cartons with codes 1510-1 (ampule) and 1510-2 (carton).
Immediately discard any recalled ampules with lot codes AB3005 to AB5008.
The product may have been contaminated during manufacturing, risking infections or organ failure in patients.
If the solution is not sterile, it could cause infections, blood clots, or organ damage.
Look for ampules with lot codes AB3005 through AB5008, which are sold in cartons labeled 1510-1 (ampule) or 1510-2 (carton).
We’ve drafted a message you can send Spectra Medical Devices to request your refund or repair — edit it as you like.
Subject: Recall Z-2873-2026 — Spectra Medical Devices Spectra Medical Devices Hello, I own a Spectra Medical Devices that is covered by recall Z-2873-2026 from Spectra Medical Devices. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
