FDA-Device2026-05-20Class IPROCESSING DEFECT
Medline Namic Angiographic Manifold recalled for particulate contamination in fluid path
What this means
Medline Industries identified particulate matter in the fluid path of certain Namic Angiographic Manifolds used in cardiopulmonary bypass procedures. The contamination could potentially affect the safety and performance of these critical medical devices during use.
- Check if your facility has Namic Angiographic Manifolds with Medline Product Number 64038200 and the affected lot numbers listed.
- Do not use affected units. Contact your Medline representative or the FDA for guidance on device replacement or return.
- Review your records to identify any patients who may have been exposed and consult your clinical team as needed.
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
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 recalls
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