Official recall record
Cranial Access Kit (ref 75061)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-02-09
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Through an internal investigation, it was identified that there is a defect in the outer packaging of the cranial access kits causing the packaging to fail the required packaging integrity testing criteria. Therefore, there is a potential sterility concern for any lots produced with this outer packaging. The outer packaging represents the sterile barrier for the cranial access kits, which are sold as single use, sterile kits. Recall start date: January 31, 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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