The Recall Desk
ModerateFDA (Devices)·Z-0016-2020·Announced 2019-10-09

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.

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, 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
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.

See all 7 products in this recall →