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Health Canada Medical devices

Quantum TTC® Biliary Balloon Dilator

Issued November 20, 2023
Issue
Wilson-Cook Medical, Inc. is initiating a voluntary removal of affected QBD devices from the market because they are nonconforming. They are manufactured correctly, but do not comply the design requirements. Devices were not able to inflate without leakage. Recall start date: November 3, 2023
Hazard description
Performance
Product
Product name
Quantum TTC® Biliary Balloon Dilator
Reference
ID
RA-74616