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Health Canada Medical devices

Affinity Fusion Oxygenators

Issued January 4, 2023
Issue
Loose Temperature Monitoring Adapter (TMA) located on the Affinity Fusion Oxygenator either during pre-procedure perfusion set up or post-procedure when disassembling the perfusion circuit. Recall start date: December 12, 2022
Hazard description
Performance
Product
Product name
Affinity Fusion Oxygenators
Reference
ID
RA-72505