Vista Dental Sodium Hypochlorite Syringes Recalled for Bung Degradation
Inter-Med LLC is recalling Vista Dental 3% Sodium Hypochlorite syringes because the rubber bung may degrade due to chemical interaction with the solution.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a potential packaging integrity issue (bung degradation) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Inter-Med LLC is recalling Vista Dental Products 3% Sodium Hypochlorite, 10-3cc Pre-filled Syringes (REF 502355). The recall involves 445 units distributed in the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia.
The affected lots may be packaged with an incorrect bung made of latex-free isoprene rubber. After prolonged storage and exposure to the contained bleach solution, the rubber bung may degrade due to chemical interaction. This degradation could potentially compromise the integrity of the syringe packaging.
Dental professionals and patients should stop using the affected syringes and contact Inter-Med LLC for instructions on return or replacement. The specific lot numbers affected are 20182545, 20182665, 20190198, 20190432, 20190724, 20190953, and 20191314.
The recalled product
- Product
- Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
- Manufacturer
- Inter-Med Llc
- Category
- Medical Device — Dental Supplies
- Affected units
- 445
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Inter-Med Llc 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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