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Health Canada Medical devices

Quadrox-I/-Id Oxygenators

Issued April 6, 2023
Issue
Maquet Cardiopulmonary GmbH (MCp) became aware of various failure modes in regard to the Quadrox-I/-Id, vhk 11000 and vkmo 10000/ 11000 products in the course of six non-conformity reports. The identified failure modes can be divided into two categories: a potentially compromised sterile barrier and a deviation from the coating specifications. Recall start date: March 28, 2023
Hazard description
Performance - Sterility
Product
Product name
Quadrox-I/-Id Oxygenators
Reference
ID
RA-73461