FDA Enforcement
Class II
Ongoing
Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.
Recall: Z-0348-2024
·
Reported November 29, 2023
Enforcement
- Recall Number
- Z-0348-2024
- Event ID
- 93222
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Aizu Olympus Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 29, 2023
- Initiation Date
- September 25, 2023
- Classification Date
- November 17, 2023
- Address
- 3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, N/A, Japan
Description
Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.
Reason
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Code Info
Model Number (UDI-DI): URF-P7 (04953170403811), URF-P7R (04953170403835), URF-V2 (04953170343582), URF-V2R (04953170343612), URF-V3 (04953170403385), URF-V3R (04953170403392).
Distribution
Worldwide - US Nationwide distribution.
Quantity
N/A