Vyon DUALSTOP White Cap used for intravascular lines Product Code:… — Class II medical device recall Z-1115-2019
Terminated recall by Vygon U.S.A., reported 2019-04-17, distributed nationwide. DualStop Caps defect causing leaks in affected product
| Recall number | Z-1115-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vygon U.S.A., Lansdale, PA, United States |
| Recall initiated | 2018-12-06 |
| Classified | 2019-04-09 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 107,700 |
| Reason classes | packaging |
| Lot numbers | 020518FD, 050418FD, 081117FD, 090718FD, 130218FD, 250118FD |
Product
Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
Reason for recall
DualStop Caps defect causing leaks in affected product
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-1115-2019. 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.