Recall Z-1701-2016— Angiodynamics Inc. (Navilyst Medical Inc.)

Name: FDA recall Z-1701-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-21

Class II · Terminated

Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2016-03-21, terminated 2017-09-18. It names one FDA 510(k) clearance: K092486. Product: Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.. Reason: Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs..

Recalling firm: Angiodynamics Inc. (Navilyst Medical Inc.)
Classification: Class II
Status: Terminated
Initiated: 2016-03-21
Terminated: 2017-09-18
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K092486 — VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUITVortex Medical, Inc.·cleared 2009-08-28

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

Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.

Reason for recall

Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.

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