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Olympus Corporation of the Americas recalls Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Recalled January 24, 2024 · FDA recall Z-0717-2024 · 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. · FDA Class II
Units
236 units
Sold at
US Nationwide. Global Distribution
Description
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.
Product
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →