THORACIC PACK , Model No UTTC82Y UTTC82AA-01
FDA Recall #Z-1361-2025 — Class II — February 6, 2025
Product Description
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
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
40 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072147332 Lots 954241 921241 889241 70-051283 70-052001 70-052096 70-053233
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated