Recall Z-1772-2024— Angiodynamics, Inc.

Name: FDA recall Z-1772-2024
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: K101843. Product: DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195. Reason: XXX.

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

K101843 — DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KITAngioDynamics, Inc.·cleared 2010-10-20

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

DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195

Reason for recall

XXX

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