Z-0716-2024 Class II Ongoing
FDA device recall Z-0716-2024 was initiated by Olympus Corporation of the Americas on December 4, 2023 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 3001 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- December 4, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3001 units
Product Description
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
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 Pattern
US Nationwide. Global Distribution
Code Information
Lot Number: All units sold prior to 2023