SOLTIVE SuperPulsed Laser Fibers recall: Foreign Material
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
Why was SOLTIVE SuperPulsed Laser Fibers recalled?
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.
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?
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
- Product
- SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 82,200 total units (5 per box)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Europe, Hong Kong, Australia, Japan, Singapore, and Latin America.
- Recall date
- January 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)