Device product
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Z-1428-2025
Product summary
- Event
- Event 96367
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4400 units
- Official record key
device-enforcement:Z-1428-2025
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 10193489067507 (each), 20193489067504 (case), Lot number 0000140528
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.