FDA-Device2026-05-20Class IPROCESSING DEFECT
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
OTHERNationwide distribution
Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Sold states
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Affected count
7075 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2138-2026More Medline Industries, LP recalls
- FDA-Device2026-05-20Medline Namic Preceptor blood pressure manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline cardiac catheterization manifold kits recalled for particulate contamination
- FDA-Device2026-05-20Medline Namic Angiographic Manifold recalled for particulate contamination in fluid path
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