ICU Medical Inc. is recalling 425,628 bottles of 0.9% Sodium Chloride Irrigation (USP 1000 mL) due to the presence of particulate matter. This recall was initiated after a customer reported seeing particles inside two semi-rigid bottles before they were used. The affected product was distributed nationwide across the United States and Puerto Rico. Consumers should check their supplies for specific lot numbers and expiration dates to ensure they do not use the contaminated solution.
The presence of particulate matter in a solution intended for irrigation poses a risk of inflammation, infection, or mechanical damage to tissues if the particles are introduced into the body during medical procedures. While one customer reported the issue, no specific injuries have been confirmed in this report.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
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.
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 · Raw API Response
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