FDA-Device2026-05-20Class IPROCESSING DEFECT
Medline Namic Angiographic Manifold recalled for particulate contamination in fluid path
What this means
Medline has identified particles in the fluid pathway of certain Namic Angiographic Manifolds used in cardiopulmonary bypass procedures. These manifolds are used to manage fluid flow during heart and lung bypass surgery. The contamination could potentially affect the safety and performance of the device during use.
- Check if you have a Namic Angiographic Manifold (Medline SKU 64038301) with one of the affected lot numbers listed in the recall notice.
- Do not use affected units; contact Medline or your healthcare facility's medical device coordinator for instructions on device replacement or return.
- If you have questions, contact Medline at the recall hotline provided in the official FDA notice.
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
38175 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2139-2026More Medline recalls
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