FDA DeviceClass INotable

FDA Recall: Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass ada

Date: 2026-05-20
Brand: Medline Industries, LP
Category: Medical Device
FDA Class: Class I

Description

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

Hazard

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

Remedy

38175 units

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