FDA DeviceClass INotable

FDA Recall: Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/S

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

107 kits

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