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

FDA Recall #Z-0717-2024 — Class II — December 4, 2023

Recall #Z-0717-2024 Date: December 4, 2023 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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.

Recalling Firm

Olympus Corporation of the Americas — Center Valley, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

236 units

Distribution

US Nationwide. Global Distribution

Code Information

Lot Number: All units sold prior to 2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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