FDA Enforcement
Class II
Ongoing
Model No. CYF-5, Cystonephrofiberscope
Recall: Z-0684-2024
·
Reported January 17, 2024
Enforcement
- Recall Number
- Z-0684-2024
- Event ID
- 93583
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Shirakawa Olympus Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- January 17, 2024
- Initiation Date
- December 4, 2023
- Classification Date
- January 9, 2024
- Address
- Azaokamiyama 3-1, Oazaodakura; Nishigo-Mura, Nishishirakawa-Gun, N/A, Japan
Description
Model No. CYF-5, Cystonephrofiberscope
Reason
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Code Info
UDI-DI: 04953170292323 04953170339417 04953170411144 All serial numbers
Distribution
US Nationwide distribution.
Quantity
3457 US; 8122 Global