Manifold Recall: Medline Removes Namic Star Off Handle Manifolds
Medline has initiated a recall of Namic Star Off Handle Manifolds due to the risk of particulate matter entering the device. The source states these particulates have the potential to be introduced into blood circulation and lodge within vessels.
This recall affects Medline, healthcare facilities utilizing Namic Star Off Handle Manifolds, and clinical teams involved in procedures where these manifolds are used to manage fluid delivery.
The presence of particulates in a fluid-path device suggests a potential failure in manufacturing quality control or material integrity. From a regulatory perspective, this indicates a significant safety risk, as internal particulate migration can lead to embolic events or vascular occlusion. Clinical and QA departments must treat this as a high-priority safety event given the direct route to systemic circulation.
Immediately identify and quarantine all affected Medline Namic Star Off Handle Manifolds. Regulatory and QA teams should initiate a retrospective review of any reported adverse events linked to embolism or particulate contamination for these lots and update risk management files accordingly.
Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
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