AV FISTULA , Model No UTAV77T
FDA Recall #Z-1356-2025 — Class II — February 6, 2025
Product Description
AV FISTULA , Model No UTAV77T
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
90 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072205179 Lots 961241 890241 70-051326 70-051979 70-053058
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated