Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir
Brand(s)
Last updated
Summary
Product
Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir | 3000358089 | VKMO 70000 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Maquet Cardiopulmonary Gmbh
Kehler Strasse 31, Rastatt, Germany, 76437
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75990
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