OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
FDA Recall #Z-1339-2025 — Class II — February 6, 2025
Product Description
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
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
90 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072219251 Lots 898241 70-050704 70-051731
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated