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Health Canada Medical devices

Approach CTO-6 and Hydro ST Microwire Guide With Hydrophylic Coating

Issued October 10, 2024
Issue
Devices from the affected device lots have labels that state the incorrect expiration dates. Preliminary investigation into this issue identified a calculation error occurred in Cook's labeling software, which uses a calculator to determine the correct expiration date. Due to this error, the calculator assigned the maximum potential shelf life to lots in scope rather than the actual shelf life. Recall Start Date: October 8, 2024
Hazard description
Labelling and packaging
Product
Product name
Approach CTO-6 and Hydro ST Microwire Guide With Hydrophylic Coating
Reference
ID
RA-76312