Device product
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Z-2139-2026
Product summary
- Event
- Event 98735
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 38175 units
- Official record key
device-enforcement:Z-2139-2026
Official wording
Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.
Code information: UDI/DI each 10193489059168, UDI/DI case 30193489059162, Lot Numbers: 89631, 92244, 92464, 93148, 94033, 94851, 101093, 101989, 103550, 109976, 112236, 112333, 114288, 115691, 121707, 126993, 137933, 142147, 162786, 191812,
Distribution pattern: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Derived failure modes
-
Foreign material or chemical contamination
particulate