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Angiodynamics Inc. (Navilyst Medical Inc.) recalls Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac
Recalled June 1, 2016 · FDA recall Z-1701-2016 · Angiodynamics Inc. (Navilyst Medical Inc.)
Hazard
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. · FDA Class II
Units
Domestic: 339 kits
Sold at
Nationwide Distribution.
Description
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.
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.
Manufacturer(s)
Angiodynamics Inc. (Navilyst Medical Inc.)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →