Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Reported: January 24, 2024 Initiated: December 4, 2023 #Z-0716-2024
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 3001 units
- Distribution
- US Nationwide. Global Distribution
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940. Recalled by Olympus Corporation of the Americas. Units affected: 3001 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0716-2024.
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