Device product
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Z-2140-2026
Product summary
- Event
- Event 98735
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1975 units
- Official record key
device-enforcement:Z-2140-2026
Official wording
Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.
Code information: UDI/DI each 10193489059182, UDI/DI case 30193489059186, Lot Numbers: 92261, 152082, 163966, 163256.
Distribution pattern: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Derived failure modes
-
Foreign material or chemical contamination
particulate