VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
FDA Recall #Z-1362-2025 — Class II — February 6, 2025
Product Description
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-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
48 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072205193 Lots 70-051418 70-052083 70-052850
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated