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Health Canada Medical devices

Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir

Issued August 30, 2024
Issue
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
Hazard description
Performance
Product
Product name
Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir
Reference
ID
RA-75990