FDA-Device2026-05-20Class IPROCESSING DEFECT
Medline Namic Angiographic Manifold recalled for particulate contamination in fluid path
What this means
Medline identified small particles present inside the fluid pathways of certain Namic Angiographic Manifolds used in cardiac bypass procedures. These manifolds are medical devices that control and direct fluid flow during heart surgery. The contamination was discovered in 1,975 units across multiple lot numbers.
- Check if your facility has any Namic Angiographic Manifolds with lot numbers 92261, 152082, 163966, or 163256.
- Do not use affected manifolds in patient procedures.
- Contact Medline Industries for replacement units and return instructions.
The agency's original wording
Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Intended for
Adults
Illnesses reported
None reported
Sold states
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Affected count
1975 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2140-2026More Medline recalls
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