Angiodynamics Inc. (Navilyst Medical Inc.) recalls AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The…

Recall date

March 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1702-2016

FDA classification

Class II

Brand / firm

Angiodynamics Inc. (Navilyst Medical Inc.)

Sold / distributed

Nationwide Distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.