Z-1263-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 22, 2022
- Initiation Date
- April 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
Reason for Recall
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
Distribution Pattern
CA FL MA MD MI NJ OH PR WI
Code Information
UDI-DI: 04953170340802 Serial Number: 2836210 2834747I