Product Wiki · Recalls · Health Canada — Medical Devices

Cranial Access Kit — recall 74655

Health Canada — Medical Devices · Canada · 2023-11-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
74655
Date of alert
2023-11-27
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Neurology
Product type
Medical devices
Reported risk: Through an internal investigation, it was identified that there is a defect in the outer packaging of the cranial access kits. This defect can cause the packaging to split without any additional forces outside of regular manufacturing and sterilization/shipping forces being applied. The outer packaging represents the sterile barrier for the cranial access kits, which are sold as single use, sterile kits. Recall start date: November 9, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cranial-access-kit

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