SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
Reported: January 24, 2024 Initiated: December 1, 2023 #Z-0748-2024
Product Description
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 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.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS. Recalled by Olympus Corporation of the Americas. Units affected: 82,200 total units (5 per box).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0748-2024.
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