Medical Saline Recalled Over Potential Fiberglass Contamination
The U.S. Food and Drug Administration (FDA) has published a recall notice for bags of intravenous saline over concerns that the solution may contain fiberglass particles, contamination that could potentially cause blood clots, organ damage or death if administered to patients.
The voluntary product recall covers two lots of ‘0.9% Sodium Chloride Injection, USP,’ a commonly used sterile medical saline solution supplied by Baxter International in 500 mL plastic bags. According to the recall notice, the affected products have lot numbers Y495523 and Y495523A and an expiration date of October 31, 2027. The affected products were distributed to healthcare providers and distributors in 14 states between July 31 and August 3 2026, according to the company.
Intravenous saline is one of the most widely used medical fluids, with applications ranging from treating dehydration and delivering medications to supporting patients undergoing medical procedures.
If administered intravenously, particles in the bloodstream can have serious consequences. The FDA notice warns that particulate matter could cause blockages and clotting in blood vessels, potentially cutting off blood flow to vital organs. This could result in a pulmonary embolism, a potentially life-threatening blood clot in the lungs, as well as permanent organ damage or death. Other possible complications include local vein irritation, inflammation, worsening of existing infections and allergic reactions.
Despite the potentially serious risks, Baxter said it had received no reports of adverse events related to the recalled lots as of August 25. The recall is the latest in a series of recent incidents involving injectable medical solutions with potential particulate contamination. Earlier this week, the company recalled one lot of anticoagulant sodium citrate solution over the potential presence of fiberglass particles and an injectable nutrition product over the potential presence of stainless steel particles.
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