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Health Canada Medical devices

Magec 2 Device

Issued November 24, 2022
Issue
Recall relates to a packaging closure integrity issue. Investigation revealed a small population (3.8%) of packaged units have an undersized o-ring gland diameter that can affect the o-ring compression when the hard cap is affixed to the packaging tube. This lack of full compression can create a situation where the integrity of the container closure system is compromised potentially impacting the sterile barrier system. Recall start date: November 1, 2022
Hazard description
Sterility
Product
Product name
Magec 2 Device
Reference
ID
RA-72218