Inter-Med Recalls Sodium Hypochlorite Syringes Due to Bung Degradation
Inter-Med Llc is recalling 1,992 units of Vista Dental Sodium Hypochlorite syringes because the rubber bung may degrade when exposed to the 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 recall is classified as FDA Class II. The hazard involves material degradation due to chemical interaction, which is a quality defect without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Inter-Med Llc is recalling 1,992 units of Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes (REF 502300). The affected lots are identified by specific work order numbers and UDI codes listed in the recall notice.
The recall is being issued because the syringes may contain an incorrect bung made of latex-free isoprene rubber. According to the source, after prolonged storage and exposure to the contained bleach solution, this rubber bung may degrade due to chemical interaction. The affected products were distributed in the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia.
Consumers and healthcare providers should check their inventory for the specific lot and UDI numbers provided in the official recall notice. If the product matches the recalled description, it should be removed from use and returned to the distributor or manufacturer for instructions.
The recalled product
- Product
- Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
- Manufacturer
- Inter-Med Llc
- Category
- Medical Device — Dental Syringes
- Affected units
- 1,992
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot/Work Order Numbers: 2018-1348 2018-1585 2018-1586 2018-1852 20182106
- UDI (01)10818207020465 20182302
- UDI (01)10818207020465 20182458
- UDI (01)10818207020465 20190725
- UDI (01)10818207020465 20190835
- UDI (01)10818207020465
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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