Device product
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Z-2148-2026
Product summary
- Event
- Event 98735
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 107 kits
- Official record key
device-enforcement:Z-2148-2026
Official wording
Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.
Code information: UDI/DI each 10193489475135, UDI/DI case 40193489475136, Lot Numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624.
Distribution pattern: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Derived failure modes
-
Foreign material or chemical contamination
particulate