Product Wiki · Recalls · Health Canada — Medical Devices

upsylon Y mesh kit (2021-04-15) — recall 62379

Health Canada — Medical Devices · Canada · 2021-04-29 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62379
Date of alert
2021-04-29
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: BSC has detected through internal testing the potential for pinholes (sterile barrier breach) on the edge of the pouch of the Colpassist Vaginal Positioning Device which are not likely to be detected by the user and may potentially render the device non-sterile.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/upsylon-y-mesh-kit-2021-04-15

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