Recall Z-2198-2018— Angiodynamics Inc. (Navilyst Medical Inc.)

Name: FDA recall Z-2198-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-10

Class II · Terminated

Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2018-05-10, terminated 2020-05-13. It names one FDA 510(k) clearance: K161866. Product: BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490. Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens)..

Recalling firm: Angiodynamics Inc. (Navilyst Medical Inc.)
Classification: Class II
Status: Terminated
Initiated: 2018-05-10
Terminated: 2020-05-13
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K161866 — BioFlo Midline CatheterNavilyst Medical, Inc.·cleared 2016-09-08

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 Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

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