Recall Z-1774-2024— Angiodynamics, Inc.

Name: FDA recall Z-1774-2024
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: K131260. Product: BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181. 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

K131260 — NMI DIALYSIS CATHETERNavilyst Medical, Inc.·cleared 2014-02-14

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

BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181

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.