FDA Issues Class I Recall for Medline Namic Manifolds Over Serious Health Risks

The U.S. Food and Drug Administration (FDA) has announced a Class I recall, the most serious type, for several Medline Namic Manifolds due to the presence of particulate within the devices' fluid paths. This recall affects Namic Angiographic, Preceptor, and Compensator Manifolds, as well as Medline Convenience Kits containing these components.

Medline identified the particulate, which poses a significant risk if introduced into a patient's bloodstream. The FDA warns that particulate in blood circulation could become lodged in blood vessels, potentially leading to serious injuries such as tissue or organ ischemia, or even death.

Customers are advised to remove the affected devices from where they are used or sold immediately. As of March 24, Medline has reported no serious injuries or deaths associated with this issue. For questions or to report adverse reactions, customers can contact Medline at recalls@medline.com or 866-359-1704.