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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 A
Recalled June 1, 2016 · FDA recall Z-1702-2016 · 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: 377 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
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.
Manufacturer(s)
Angiodynamics Inc. (Navilyst Medical Inc.)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →