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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