MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
FDA Recall #Z-1334-2025 — Class II — February 6, 2025
Product Description
MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
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
17 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072222824 00191072223890 Lots 879241 70-052915
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated