Health Canada — Medical Devices · Canada · 2024-05-08 · Type II
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Reported risk: The decision to conduct a voluntary removal of the product was based on the following: through an internal investigation, it was identified that there is a defect (potential holes and tears) in the sterile packaging (header bag) of the cranial access kit which creates a potential sterility concern. The header bag represents the sterile barrier for the cranial access kit, which is sold as a single use, sterile kit. Recall start date: May 1, 2024
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