Z-1356-2025 Class II Ongoing

Recalled by American Contract Systems Inc — Tiffin, OH

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
90 kits

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.

Distribution Pattern

US Nationwide distribution in the state of OH.

Code Information

UDI-DI 00191072205179 Lots 961241 890241 70-051326 70-051979 70-053058