NEURO IR TRAY , Model No WENI56J
FDA Recall #Z-1355-2025 — Class II — February 6, 2025
Product Description
NEURO IR TRAY , Model No WENI56J
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
120 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072217813 Lots 893241 71-051182 71-051813
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated