DIAGNOSTIC NEURO IR TRAY , Model No WENE21
FDA Recall #Z-1354-2025 — Class II — February 6, 2025
Product Description
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
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
170 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072212900 00191072218001 Lots 960241 71-050727 71-051234 71-051771 71-052322 71-052501 71-052705
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated