medical Class II Updated 2024-01-24

Olympus Corporation of the Americas recalls Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Nu

Recalled Product

Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: All units sold prior to 2023
View official government recall

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