FDAHealthMarch 24, 2026

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

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

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: March 24, 2026

US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.

What's affected?

Product: Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Brand: Medline Industries, LP
Lot code: 89631

Additional details

UDI/DI each 10193489059168, UDI/DI case 30193489059162, Lot Numbers: 89631, 92244, 92464, 93148, 94033, 94851, 101093, 101989, 103550, 109976, 112236, 112333, 114288, 115691, 121707, 126993, 137933, 142147, 162786, 191812,

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 38175 units.

View original FDA notice →

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