SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
This recall is currently active, issued January 12, 2024. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- December 4, 2023
- Posted
- January 12, 2024
- Recall Number
- Z-0718-2024
- Quantity
- 179 units
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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).
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.
Lot / Code Info
UDI-DI 00821925043985 Lot KR262848
Root Cause
Under Investigation by firm
Action Taken
On December 4, 2023, the firm notified affected customers via Urgent Medical Device Removal letters. Customers were instructed to identify and quarantine the affected model/lot. Affected product should not be used. Olympus will issue a credit to customers upon the return of the affected product. If product was distributed outside the customer's facility, the customer should notify those outside facilities immediately. If you require additional information, please contact the company by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com.