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Recall Observatory FDA recall evidence

Device product

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24

Z-1284-2025

February 13, 2025

Class I

Product summary

Firm
Smiths Medical ASD, Inc.
Event
Event 96294
Status
Ongoing
Classification
Class I
Quantity
1 unit
Official record key
device-enforcement:Z-1284-2025

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 10610586012723, Lot Numbers: 4235509

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing defect