Product Wiki · Recalls · Health Canada — Medical Devices

Kii Optical Access System (2021-05-18) — recall 62498

Health Canada — Medical Devices · Canada · 2021-06-10 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62498
Date of alert
2021-06-10
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Applied Medical has identified that some boxes of CFR03 Kii Optical Access System contain an incorrect IFU. The boxes with the incorrect IFU contain the Kii Fios First Entry IFU, rather than the correct Kii Optical Access System IFU. Both systems have the same indications.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/kii-optical-access-system-2021

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