Class I

Medical Device Recall: smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24

Smiths Medical ASD, Inc. · February 13, 2025

Reason for Recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Distribution

Worldwide distribution.

Quantity Affected

9506 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1280-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.