FDA recall Z-1288-2025

Smiths Medical ASD, Inc. · Class I · device

Product

smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

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-1288-2025