FDA-Device2025-03-26Class I

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

Smiths Medical ASD, Inc.
Hazard

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

Sold states
Worldwide distribution.
Affected count
2311 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1279-2025

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