FDA recall Z-1285-2025

Smiths Medical ASD, Inc. · Class I · device

Product

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

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.

Key facts

Status: Ongoing
Initiation date: 2025-02-13
Report date: 2025-03-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1285-2025