Soltive SuperPulsed Laser System TFL FIBER CLEAVER recall: Sterility Concern
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Why was Soltive SuperPulsed Laser System TFL FIBER CLEAVER 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: All units sold prior to 2023
- Product
- Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 236 units
- Distribution
- US Nationwide. Global Distribution
- Recall date
- January 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)