The U.S. Food and Drug Administration (FDA) has issued a safety alert for Medline’s Namic Star off-handle manifolds following reports that particulate matter may enter blood circulation during use. The recalled medical devices carry the risk of particles becoming lodged in blood vessels, potentially causing serious vascular complications in patients.
The Namic Star manifold line is widely used in medical facilities for fluid administration and blood draw procedures. Healthcare providers and hospital systems currently using these devices should immediately cease use and review their existing inventory. The scope and number of affected units are being assessed by both Medline and the FDA.
The FDA is coordinating with Medline to implement a full product recall and conduct a root cause investigation into the particulate contamination issue. Healthcare facilities should report any adverse events or patient injuries related to these manifolds to the FDA MedWatch program. This is a developing story.
Source: Manifold Recall: Medline Removes Namic Star Off Handle Manifolds
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