FDA Issues Early Alert for Medical Action Industries Convenience Kit Recall

The U.S. Food and Drug Administration (FDA) has issued an early alert regarding a medical device recall by Medical Action Industries for certain Convenience Kits. These kits contain Medline’s Namic Angiographic Star Off Handle Manifolds, which have been found to contain particulate matter.

Medline identified particulate within the fluid path of the Manifolds. This poses a serious risk, as the particulate could enter a patient's bloodstream, potentially leading to severe injuries such as tissue or organ ischemia, or even death.

Affected devices include the "Pack Angiography NCMC 3/Cs BANNER" kit, identified by UDI 20809160490416, and specific lots: 342513, 336758, and 338977. Medical Action Industries has advised customers to remove these Convenience Kits from use or sale immediately.

Customers with questions or concerns about this issue should contact Medical Action Industries at complaints@owens-minor.com.