Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

smiths medical ProPort Plastic Venous Access System Recalled by Smiths Medical ASD, Inc. Due to The plastic port housing and port reservoir of...

Date: February 13, 2025
Company: Smiths Medical ASD, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD, Inc. directly.

Affected Products

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24

Quantity: 3263 units

Why Was This Recalled?

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

Where Was This Sold?

Worldwide distribution.

About Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc. has 114 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report