Medline Industries, LP — Class I: Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-
Medline Industries, LP has initiated a Class I recall for specific medical convenience kits containing Namic Manifolds due to the identification of particulate matter within the fluid path. The affected products are labeled as HEART CATH PACK-LF, specifically Medline Kit Number/SKU DYNJ36478B.
This affects Medline Industries, LP, healthcare providers utilizing cardiology convenience kits, and hospital departments involved in cardiac catheterization and interventional radiology.
A Class I designation indicates the FDA's assessment of a high risk for serious adverse health consequences or death. The presence of particulate in a fluid path—especially in a cardiac catheterization context—presents significant safety risks such as embolism or vascular occlusion. Regulatory teams may view this as a critical failure in supplier quality oversight or component inspection, as the issue originates within a sub-component (Namic Manifold) of a larger convenience kit.
Affected facilities should immediately identify and sequester kit number DYNJ36478B. Quality and supply chain teams should verify that all potentially affected inventory is accounted for and coordinate with the manufacturer for disposal or return procedures as per the Class I recall notification.
Class I. Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.. Product: Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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