Huons Co. recalls 10mL sodium chloride injection ampules due to lack of sterility assurance. This may cause infections if used improperly. Affected lots are all within expiry dates.
Lack of Assurance of Sterility
Huons Co. is recalling 10mL sodium chloride injection ampules because they lack sterility assurance. This could lead to infections if the product is used without proper sterilization.
The product lacks sterility assurance, meaning it could be contaminated with bacteria. If used without proper sterilization, this could lead to infections in patients.
Prescription patients who received this specific injection product. Healthcare providers using the product for medical treatments may also be affected.
Check for the product name: 0.9% Sodium Chloride Injection, USP, 10 mL Ampules. The product is prescription-only and manufactured for Spectra Medical Devices, LLC. All lots within expiry dates are affected.
Look for the product name and manufacturer information on the ampule label.
The product lacks sterility assurance, so it may be contaminated and could cause infections if used improperly.
Check for the product name: 0.9% Sodium Chloride Injection, USP, 10 mL Ampules. The product is prescription-only and manufactured for Spectra Medical Devices, LLC.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Huons Co. to request your refund or repair — edit it as you like.
Subject: Recall D-0531-2026 — Huons Co. Huons Co. Hello, I own a Huons Co. that is covered by recall D-0531-2026 from Huons Co.. 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.