FDA Enforcement
Class II
Ongoing
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Recall: Z-0717-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0717-2024
- Event ID
- 93613
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- December 4, 2023
- Classification Date
- January 12, 2024
- Address
- 3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States
Description
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Reason
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.
Code Info
Lot Number: All units sold prior to 2023
Distribution
US Nationwide. Global Distribution
Quantity
236 units