Device product
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
Z-2230-2023
Product summary
- Event
- Event 92570
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1245 units
- Official record key
device-enforcement:Z-2230-2023
Official wording
Reason: Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Code information: GTIN: 08714729978664 Lot Numbers: 2030305543, 30305544, 30305545, 30305546, 30305547, 30305548, 30305549, 30389370, 30389371, 30389372, 30389373, 30389375, 30389376, 30389377, 30389378, 30429835, 30429837, 30479586, 30479587, 30479589, 30479590, 30521464, 30521466, 30521467, 30521468, 30554456, 30554457. Exp. Date: 7-Oct-2025 to 16-Nov-2025
Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.
Derived failure modes
-
Unknown
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched