Olympus Corporation of the Americas Recall 93613
Description: Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Olympus Corporation of the Americas Recall 93613 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0716-2024 |
| Event ID | 93613 |
| Event Description | Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940 |
| Product Type | Devices |
| Distribution | US Nationwide. Global Distribution |
| Quantity | 3001 units |
| Recall 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. |
| Device Classification | 20240124 |
| Device Code Info | Lot Number: All units sold prior to 2023 |
| Center Classification Date | 20240112 |
| Recall Initiation Date | 20231204 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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