Recall Z-1761-2024— Angiodynamics, Inc.

Name: FDA recall Z-1761-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-18

Class II · Ongoing

Class II FDA medical device recall by Angiodynamics, Inc., initiated 2024-03-18. It names one FDA 510(k) clearance: K110936. Product: DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021. Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure..

Recalling firm: Angiodynamics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-03-18
Firm location: Queensbury, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K110936 — DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KITAngioDynamics, Inc.·cleared 2011-06-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.