MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
FDA Recall #Z-1358-2025 — Class II — February 6, 2025
Product Description
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
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
147 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072205100 00191072217370 Lots 974241 884241 70-051159 70-052011 70-052602 70-053158
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated