Z-2228-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2023
- Initiation Date
- May 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 units
Product Description
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
Reason for Recall
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
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
GTIN: 08714729978572 Lot Number: 30554442 Exp. Date: 16-Nov-2025