Device product
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Z-1429-2025
Product summary
- Event
- Event 96367
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-1429-2025
Official wording
Reason: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Code information: UDI/DI 10193489064803 (each), 20193489064800 (case), Lot number 0000140054
Distribution pattern: Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
Derived failure modes
-
Unknown
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.