FDA-Device2016-06-01Class II
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.
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.
Sold states
Nationwide Distribution.
Affected count
Domestic: 377 kits
Manufactured in
10 Glens Falls Tech Park, N/A, Glens Falls, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1702-2016Don't want to check this manually?
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