Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DURAFLOW 2 Recalled by Angiodynamics, Inc. Due to Tri-Ball Tunneler may contain loosely affixed metal shavings,...

Date: March 18, 2024
Company: Angiodynamics, 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 Angiodynamics, Inc. directly.

Affected Products

DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115

Quantity: 188 units

Why Was This Recalled?

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Where Was This Sold?

This product was distributed to 1 state: VA

Affected (1 state)Not affected

About Angiodynamics, Inc.

Angiodynamics, Inc. has 74 total recalls tracked by RecallDetector.

Related Recalls

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