Device product
namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
Z-1430-2025
Product summary
- Event
- Event 96367
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-1430-2025
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 10193489070279 (each),20193489070276 (case), Lot number 0000141266
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.