FDA-Device2024-01-24Class II
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Olympus Corporation of the Americas
Hazard
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.
Sold states
US Nationwide. Global Distribution
Affected count
236 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0717-2024Don't want to check this manually?
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