SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
This recall is currently active, issued January 18, 2024. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- December 1, 2023
- Posted
- January 18, 2024
- Recall Number
- Z-0748-2024
- Quantity
- 82,200 total units (5 per box)
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Europe, Hong Kong, Australia, Japan, Singapore, and Latin America.
Lot / Code Info
Models UDI/GTIN TFL-FBX150S 00821925043916 TFL-FBX200S 00821925043930 TFL-FBX365S 00821925043992 TFL-FBX550S 00821925044036 TFL-FBX940S 00821925044074 TFL-FBX150BS 00821925043879 TFL-FBX200BS 00821925043978 All lots affected
Root Cause
Labeling Change Control
Action Taken
On December 1, 2023, the firm issued URGENT MEDICAL DEVICE CORRECTION letters to affected customers. Customers were provided with copies of the labeling addendum to add to remaining inventory. Customers may continue to use the product, but this should be done in accordance with the labeling addendum. If you require additional information, please contact Olympus at (647) 999-3203 or at Cynthia.Ow@Olympus.com.