PlainRecalls
FDA Devices Moderate Class II Ongoing

DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01

Reported: March 26, 2025 Initiated: February 6, 2025 #Z-1332-2025

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.

Details

Units Affected
1200 kits
Distribution
US Nationwide distribution in the state of OH.
Location
Tiffin, OH

Frequently Asked Questions

What product was recalled?
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01. Recalled by American Contract Systems Inc. Units affected: 1200 kits.
Why was this product recalled?
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1332-2025.