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High severity

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

SourceFDA Device Enforcement
CategoryMedical Device
SeverityHigh
Statusongoing
Recall dateMarch 24, 2026
ReportedMay 20, 2026
Recalling firmMedline Industries, LP
Country / regionUnited States IL

Hazard

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Affected products

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