Device product
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Z-1286-2025
Product summary
- Event
- Event 96294
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 0 units
- Official record key
device-enforcement:Z-1286-2025
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 10610586012754, Lot Numbers: 4196769
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing defect