PlainRecalls
FDA Devices Moderate Class II Ongoing

URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03

Reported: March 26, 2025 Initiated: February 6, 2025 #Z-1345-2025

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.

Details

Units Affected
41 kits
Distribution
US Nationwide distribution in the state of OH.
Location
Tiffin, OH

Frequently Asked Questions

What product was recalled?
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03. Recalled by American Contract Systems Inc. Units affected: 41 kits.
Why was this product recalled?
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1345-2025.