The Recall Desk
ModerateFDA (Devices)·Z-0017-2020·Announced 2019-10-09

Inter-Med Recalls Chlor-XTRA Syringes Due to Bung Degradation Risk

Inter-Med Llc is recalling specific lots of Chlor-XTRA prefilled syringes because the rubber bung may degrade when exposed to 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, but the source text describes a potential degradation issue without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.

Plain-English summary

Inter-Med Llc is recalling 384 units of Vista Dental Products Chlor-XTRA 12mL Prefilled Syringes (REF 503850). The affected lots were distributed in the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia.

The recall is due to a potential defect in the syringe packaging. The affected syringes may contain an incorrect bung made of latex-free isoprene rubber. According to the source text, after prolonged storage and exposure to the contained bleach solution, the rubber bung may degrade due to chemical interaction.

No specific instructions for consumers are provided in the source text. Affected lots include Work Order Numbers 2018-1471, 2018-1992, 20182211, and specific UDI codes listed in the recall metadata.

The recalled product

Product
Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
Manufacturer
Inter-Med Llc
Affected units
384

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 (5)

  • Lot/Work Order Numbers: 2018-1471 2018-1992 20182211
  • UDI (01)10818207020502 20182779
  • UDI (01)10818207020502 20190041
  • UDI (01)10818207020502 20190309
  • UDI (01)10818207020502

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 →