FDA-Device2025-03-26Class I
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
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
1961 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1283-2025Don't want to check this manually?
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