Device product
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
Z-2146-2026
Product summary
- Event
- Event 98735
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 0 kits
- Official record key
device-enforcement:Z-2146-2026
Official wording
Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.
Code information: UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 26CMC977
Distribution pattern: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Derived failure modes
-
Foreign material or chemical contamination
particulate