Device product
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
Z-1345-2025
Product summary
- Event
- Event 96343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 41 kits
- Official record key
device-enforcement:Z-1345-2025
Official wording
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Code information: UDI-DI 00191072136688 Lots 905241 70-050739 70-051020 70-051480 70-051606 70-051888
Distribution pattern: US Nationwide distribution in the state of OH.
Derived failure modes
-
Unknown
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.