Health product recall

TFL Fiber Cleaver and Stripper

Brand(s)
Last updated

Summary

Product
TFL Fiber Cleaver and Stripper
Issue
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

TFL Fiber Cleaver

All lots.

TFL-AFC

TFL Fiber Stripper

All lots.

TFL-AFS550
TFL-AFS365
TFL-AFS940
TFL-AFS150
TFL-AFS200

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Gyrus Acmi, Inc

9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74795

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