DR DIULUS Injection Pack Models Recalled for Sterilization Assurance Issues
American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for sterilization assurance failure on injection equipment with no reported illnesses or injuries. Classified as risk-of-harm product where injury has not yet been reported, per severity rubric.
Plain-English summary
American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits (Models CCDU12C, CCDU12D, and CCDU12D-01) that were distributed in Ohio. The manufacturer is unable to confirm that sterilization assurance requirements were met during manufacturing.
If sterilization procedures were not properly followed, the affected injection packs may lack proper sterility. This could result in loss of functionality, potentially leading to treatment delays or the need for prolonged medical care.
Healthcare providers and patients who may have received these injection packs should contact American Contract Systems Inc or the FDA for guidance on whether their specific units are affected by this recall.
The recalled product
- Product
- DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device
- Hazard
- sterilization-failure
- loss-of-functionality
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27