Public recall detail

Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir

2024-08-30

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Recall Safety notice
Quick summary

Quick summary: Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir. Date: 2024-08-30.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir. Date: 2024-08-30.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandMAQUET CARDIOPULMONARY GMBH
ProductQuadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75990

Affected products

ProductQuadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir
Lot3000358089
ModelVKMO 70000
Serial number3000358089
DescriptionQuadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesMaquet Cardiopulmonary Gmbh Kehler Strasse 31, Rastatt, Germany, 76437
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75990
Background{}
CompaniesMaquet Cardiopulmonary Gmbh Kehler Strasse 31, Rastatt, Germany, 76437
AudiencesHealthcare
Source updated2024-08-30

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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