DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
FDA Recall #Z-1332-2025 — Class II — February 6, 2025
Product Description
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-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
1200 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
1. Model No. CCDU12C UDI-DI 00191072196323 Tray Lots 968241 70-050508 70-050945 70-051497 70-051882 2. Model No. CCDU12D UDI-DI 00191072229472 Tray Lot 70-052444 3. Model No. CCDU12D-01 UDI-DI 00191072229472 Tray Lot 70-052967
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated