Device product
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Z-2142-2026
Product summary
- Event
- Event 98735
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 760 units
- Official record key
device-enforcement:Z-2142-2026
Official wording
Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.
Code information: UDI/DI each 10193489059205, UDI/DI case 30193489059209, Lot Numbers: 117277, 119982, 122210, 122199, 130129, 133014, 136396, 138613, 139138, 157974, 162399, 164317, 175538, 193515, 193531.
Distribution pattern: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Derived failure modes
-
Foreign material or chemical contamination
particulate