EAR PACK , Model No SFEA12A
FDA Recall #Z-1351-2025 — Class II — February 6, 2025
Product Description
EAR PACK , Model No SFEA12A
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
51 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072167446 Lots 968241 888241 70-052114 70-052727 70-053132
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated