SOLTIVE SuperPulsed Laser Fibers recall
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Why was SOLTIVE SuperPulsed Laser Fibers recalled?
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
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?
UDI-DI 00821925043985 Lot KR262848
- Product
- SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 179 units
- Distribution
- Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin America, and Europe.
- Recall date
- January 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)