FDAFDA · Food and drugs·Recall number Z-0717-2024
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Published January 24, 2024 · Recall initiated: December 4, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide. Global Distribution
- Lot
- Lot Number: All units sold prior to 2023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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