FDA recall Z-0717-2024

Olympus Corporation of the Americas · Class II · device

Product

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.

Distribution

US Nationwide. Global Distribution

Key facts

Status: Ongoing
Initiation date: 2023-12-04
Report date: 2024-01-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0717-2024