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Official recall record

Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir

Health Canada — Medical Devices · 2024-08-30 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-08-30
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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