Official recall notice

FDA DeviceClass INotable

FDA Recall: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.

Recall date
2026-08-12
FDA class
Class I

Why it was recalled

Hazard

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

Product description

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

Affected products

UDI-DI 10809160408650 Lots 1618351 1621441 1627930 1635908 1644501 1646021 1651957 1654887 1656581 1656582 1659713 1670884 1670885 1671950

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