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Health Canada Medical devices

20/30 Priority Pack Accessory Kit With Copilot and 20/30 Indeflator Inflation Device

Issued November 21, 2024
Issue
This action is being taken due to an increased potential for a leak in the indeflator at the hose rotating luer or at the guage. Analysis indicates an estimated rate of occurrence of leaks ranging from 0.3% to 2.3% across the impacted lots. While no adverse patient effects have been reported with this issue, potential risks include air embolism. Recall Start Date: November 6, 2024
Hazard description
Performance
Product
Product name
20/30 Priority Pack Accessory Kit With Copilot and 20/30 Indeflator Inflation Device
Reference
ID
RA-76554