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Tfl fiber cleaver and stripper

Official notice

27 Dec 2023

Last checked

27 Dec 2023

Medium riskHealth Canada

An official Health Canada notice concerns Tfl fiber cleaver and stripper. 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 Published 2023-12-27.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74795

Official notice

2023-12-27

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74795

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Affected products

Product 1

Affected products - TFL Fiber Cleaver, Lot or serial number - All lots., Model or catalog number - TFL-AFC

Product 2

Affected products - TFL Fiber Stripper, Lot or serial number - All lots., Model or catalog number - TFL-AFS550 TFL-AFS365 TFL-AFS940 TFL-AFS150 TFL-AFS200

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Gyrus Acmi, Tfl Fiber Cleaver And Stripper.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74795

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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