Vista Dental CanalClean Endodontic Irrigation Kit Recalled for Bung Degradation
Inter-Med LLC is recalling Vista Dental CanalClean kits because the rubber bung may degrade when exposed to bleach solution.
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 2/5 (Moderate).
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: The FDA classified this as a Class II recall. The source text does not report any illnesses or injuries, and the hazard is described as a potential degradation of the bung material, which fits the criteria for a moderate severity recall involving a theoretical or low-risk defect.
Plain-English summary
Inter-Med LLC is recalling Vista Dental Products CanalClean Endodontic Irrigation Kits, Reference 504700. The recall involves 377 units distributed in the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia. The affected lots are identified by work order numbers 2018-1192, 2018-1473, 2018-1742, 2018-1999, 2018-2386, 2018-2741, and 2019-0047.
The recall is due to a potential defect in the syringe packaging. The affected lots may be packaged with an incorrect bung made of latex-free isoprene rubber. According to the source, after prolonged storage and exposure to the contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
- Manufacturer
- Inter-Med Llc
- Category
- Medical Device — Dental
- Hazard
- Affected units
- 377
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.
See all 7 products in this recall →Related recalls
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