Inter-Med Recalls Sodium Hypochlorite Syringes Due to Bung Degradation
Inter-Med Llc is recalling 582 units of Vista Dental Products Sodium Hypochlorite syringes because the rubber bung may degrade after prolonged storage.
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: The recall is classified as FDA Class II, but the source text describes a potential material degradation issue without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Inter-Med Llc is recalling 582 units of Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes (REF 502315). The recall affects specific lots and work order numbers, including 2018-1349, 2018-1587, 2018-1853, and 20182107, as well as units with specific UDI codes.
The affected 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, the rubber bung may degrade due to chemical interaction. The product was distributed in the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia.
Healthcare providers and consumers should check their inventory for the specific lot and work order numbers listed in the recall notice. If the product matches the affected lots, it should be removed from use and returned to the distributor or manufacturer for credit or replacement.
The recalled product
- Product
- Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
- Manufacturer
- Inter-Med Llc
- Category
- Medical Device — Dental Supplies
- Affected units
- 582
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 (7)
- Lot/Work Order Numbers: 2018-1349 2018-1587 2018-1853 20182107
- UDI (01)10818207020427 20182303
- UDI (01)10818207020427 20182584
- UDI (01)10818207020427 20182666
- UDI (01)10818207020427 20190199
- UDI (01)10818207020427 20190433
- UDI (01)10818207020427
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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