FDAHealthMarch 24, 2026
Medline Industries, LP — Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; 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 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
- Lot code
- 92261
Additional details
UDI/DI each 10193489059182, UDI/DI case 30193489059186, Lot Numbers: 92261, 152082, 163966, 163256.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 1975 units.
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