FDAFDA · Food and drugs·Recall number Z-2140-2026
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Published May 20, 2026 · Recall initiated: March 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
- Lot
- UDI/DI each 10193489059182, UDI/DI case 30193489059186, Lot Numbers: 92261, 152082, 163966, 163256.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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