Official recall record
Approach CTO-6 and Hydro ST Microwire Guide With Hydrophylic Coating
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-10-10
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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