Device product
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
Z-2141-2026
Product summary
- Event
- Event 98735
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 6390 units
- Official record key
device-enforcement:Z-2141-2026
Official wording
Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.
Code information: UDI/DI each 10193489059137, UDI/DI case 30193489059131, Lot Numbers: 89181, 95326, 95254, 102287, 102286, 102706, 105362, 105558, 108608, 112242, 112243, 115437, 118477, 121180, 121645, 122708, 126024, 131603, 136583, 140860, 142371, 146728, 147474, 148571, 152020, 153175, 163216, 175580, 176810, 184394, 191388, 193141.
Distribution pattern: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Derived failure modes
-
Foreign material or chemical contamination
particulate