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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1,200
Distribution
Part of a larger recall action
This product is one of 32 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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