URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
FDA Recall #Z-1345-2025 — Class II — February 6, 2025
Product Description
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
Reason for Recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Recalling Firm
American Contract Systems Inc — Tiffin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
41 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072136688 Lots 905241 70-050739 70-051020 70-051480 70-051606 70-051888
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated