Z-1345-2025 Class II Ongoing
FDA device recall Z-1345-2025 was initiated by American Contract Systems Inc on February 6, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 41 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 kits
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.
Distribution Pattern
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