OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
FDA Recall #Z-1359-2025 — Class II — February 6, 2025
Product Description
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
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
54 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072184450 00191072221070 Lots 921241 70-051173 70-052439
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated