The U.S. Food and Drug Administration (FDA) has issued a safety alert for Medline’s Namic Star off-handle manifolds following reports of a critical manufacturing defect. The devices, used in medical settings for fluid delivery and monitoring, carry the risk of introducing particulate matter into the bloodstream during clinical use.
According to the FDA alert, particulates generated during device operation have the potential to enter blood circulation and lodge within blood vessels, posing serious harm to patients. The recall affects all Namic Star manifold units distributed by Medline Industries. Healthcare facilities currently using these devices should immediately cease use and contact Medline for replacement or return instructions.
The FDA is actively monitoring the situation and has directed Medline to implement corrective actions. Healthcare providers are advised to review their inventory, notify affected patients if applicable, and report any adverse events to the FDA MedWatch program. This is a developing story.
Source: Manifold Recall: Medline Removes Namic Star Off Handle Manifolds
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