FDA Device recall Z-1114-2019
Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines
- FDA Device
- Class II
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class II recall of Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines by Vygon U, citing dualStop Caps defect causing leaks in affected product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1114-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-06 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Vygon U |
| Distribution | US |
Product
Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
Reason
DualStop Caps defect causing leaks in affected product
Identifiers
| code_info | Lot codes: 310518FD 050618FD 140318FD 160617FD 200917FD 061117FD 090118FD 200218FD 290318FD 110418FD |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1114-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.