Device product
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Z-1277-2025
Product summary
- Event
- Event 96294
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1277-2025
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 10610586012518, Lot Number 4235595
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing defect