Vista Dental Products Chlor-XTRA — Class II medical device recall Z-0016-2020
Terminated recall by Inter-Med Llc, reported 2019-10-09. The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a
| Recall number | Z-0016-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inter-Med Llc, Racine, WI, United States |
| Recall initiated | 2019-06-27 |
| Classified | 2019-10-01 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2021-08-10 |
| Countries outside the US | AU, CH, IT, PL, SG, ZA |
| Quantity | 58 units |
| Reason classes | chemical contamination |
| UPC / GTIN / UDI-DI | 10818207020496 |
| Model numbers | 503825 |
Product
Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
Reason for recall
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0016-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.