Z-2245-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2025
- Initiation Date
- June 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 166 units
Product Description
DAVINCI UROLOGY. Medical convenience kit.
Reason for Recall
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Distribution Pattern
Domestic: CA, IL, MD, OH, PA, TX, WA.
Code Information
Model No. WRNM038-09, WRNM038-10, WRNM038-11; UDI: 10809160369302, 10809160418338, 10809160432259; Kit Lot No. 1589886, 1593087, 1606686, 1606688, 1615262, 1611133, 1627007.