Device product
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
Z-1285-2025
Product summary
- Event
- Event 96294
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 12 units
- Official record key
device-enforcement:Z-1285-2025
Official wording
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Code information: UDI/DI 10610586012747, Lot Numbers: 4317077
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing defect