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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Vet
Medications & Supplements/Veterinary Medicines

0.9% Sodium Chloride Irrigation Recalled for Particulate Matter

Agency Publication Date: March 23, 2021
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Summary

ICU Medical Inc. is recalling 59,076 bottles of 0.9% Sodium Chloride Irrigation, USP 1000 mL Semi-Rigid Bottle due to the presence of particulate matter. No incidents or injuries have been reported. The affected products include specific lot numbers 16-808-4B, 16-803-4B, and 16-809-4B, all with an expiration date of April 1, 2023. If you have concerns, contact your veterinarian, then return any unused product to the place of purchase for a refund or dispose of it.

Risk

Injecting solutions containing particulate matter can lead to severe health consequences such as local irritation, allergic reactions, inflammation, or blockages in blood vessels, potentially resulting in serious injury or death. No incidents or injuries have been reported related to this recall.

What You Should Do

  1. Check your 0.9% Sodium Chloride Irrigation, USP 1000 mL Semi-Rigid Bottle for NDC 0990-7138-09.
  2. Identify the lot number on the bottle. The affected lot numbers are 16-808-4B, 16-803-4B, and 16-809-4B, all with an expiration date of April 01, 2023.
  3. If you have any of the recalled product, stop using it immediately.
  4. If you have animal health concerns, contact your veterinarian for guidance.
  5. Return any unused product to the place of purchase for a refund, or dispose of it properly.
  6. For additional questions, call the FDA at 1-888-INFO-FDA (1-888-463-6332).

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, or contact the manufacturer or supplier for further instructions
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: 0.9% Sodium Chloride Irrigation, USP 1000 mL Semi-Rigid Bottle
Lot Numbers:
16-808-4B (Exp April 01, 2023)
16-803-4B (Exp April 01, 2023)
16-809-4B (Exp April 01, 2023)
NDC:
0990-7138-09

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87485
Status: Resolved
Manufacturer: ICU Medical Inc
Manufactured In: United States
Units Affected: 59,076 bottles
Distributed To: Nationwide
Agency Last Updated: March 31, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response