Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir

Maquet Cardiopulmonary's monthly inspection of oxygenators for the presence of the Softline coating revealed that two out of ten oxygenators tested did not pass. The Softline coating is a vital component in the biocompatibility of blood contact components used in extracorporeal circulation. This means that the oxygenators installed in the products listed above do not have the Softline coating. The issue is limited to one lot number in Canada.

Recall Start Date: August 20, 2024