Inter-Med Recalls Chlor-XTRA Dental Syringes Due to Bung Degradation
Inter-Med LLC is recalling Chlor-XTRA prefilled syringes because the bung may degrade from chemical interaction with 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, and the hazard involves potential material 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 Chlor-XTRA 3mL prefilled syringes. The recall involves 58 units of the product, identified by reference number 503825 and lot numbers 20190565 and 20191107.
The affected lots may be packaged with an incorrect bung made of latex-free isoprene rubber. According to the recall notice, after prolonged storage and exposure to the contained bleach solution, the rubber bung may degrade due to chemical interaction. This degradation could potentially affect the integrity of the syringe packaging.
The product was distributed in the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia. Consumers and healthcare providers should check their inventory for the specific lot numbers and reference number listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer.
The recalled product
- Product
- Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
- Manufacturer
- Inter-Med Llc
- Category
- Medical Device — Dental Syringes
- Affected units
- 58
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 (1)
- UDI (01)10818207020496 Lot/Work Order Numbers: 20190565 20191107
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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