FDA (Devices) recall action 73815
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Angiodynamics is recalling Vortex MEDICAL AngioVac Circuits because they may contain endotoxin levels exceeding regulatory limits.
AngioDynamics is recalling AngioVac Circuit Packs because they may contain RotaFlow Centrifugal Pumps with endotoxin levels exceeding regulatory limits.