FDAHealthMarch 24, 2026
Medline Industries, LP — Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; 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 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
- Lot code
- 90184
Additional details
UDI/DI each 10193489059144, UDI/Di case 30193489059148, Lot Numbers: 90184, 94779, 97786, 106351, 108597, 109876, 114056, 114989, 115459, 115931, 116358, 116865, 118245, 122974, 126077, 127795, 129531, 130557, 136114, 150501, 151591, 152772, 154514, 156045, 160318, 163255, 168053.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 7075 units.
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