Product Wiki · Recalls · Health Canada — Medical Devices

TFL Fiber Cleaver and Stripper — recall 74795

Health Canada — Medical Devices · Canada · 2023-12-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
74795
Date of alert
2023-12-27
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Orthopaedics
Product type
Medical devices
Reported risk: Olympus is taking this medical device recall action after a review of reprocessing instructions for the Fiber Strippers and Cleavers. Both the strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination. Recall Start Date: December 11, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/tfl-fiber-cleaver-and-stripper

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